| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 04056869014234 | 07577732 | MRI Coil | LNI,MOS,LNH | System, nuclear magnetic resonance spectroscopic,Coil, magnetic resonance, speci System, nuclear magnetic resonance spectroscopic,Coil, magnetic resonance, specialty,System, nuclear magnetic resonance imaging | 2 | Head Matrix MR Coil | |
| 2 | 04056869014012 | 11060606 | JAK | System, x-ray, tomography, computed | 2 | syngo.CT Dental | ||
| 3 | 04056869013046 | 10046734 | JAK | System, x-ray, tomography, computed | 2 | Somatom Perspective (DE) | ||
| 4 | 04056869013039 | 10046733 | JAK | System, x-ray, tomography, computed | 2 | Somatom Perspective (DE) | ||
| 5 | 04056869014104 | 05512038 | MRI Coil | LNI,LNH,MOS | System, nuclear magnetic resonance spectroscopic,System, nuclear magnetic resona System, nuclear magnetic resonance spectroscopic,System, nuclear magnetic resonance imaging,Coil, magnetic resonance, specialty | 2 | FLEX SMALL 047 CPL. | |
| 6 | 04056869008844 | 04809815 | JAK | System, x-ray, tomography, computed | 2 | Insert Osteo mat | ||
| 7 | 04056869008820 | 03810962 | JAK | System, x-ray, tomography, computed | 2 | Osteo CT P10 | ||
| 8 | 04056869285801 | 11582847 | LLZ | System, image processing, radiological | 2 | syngo.via | ||
| 9 | 04056869267234 | 11407657 | MOS | Coil, magnetic resonance, specialty | 2 | BM Contour L Coil | ||
| 10 | 04056869267227 | 11407658 | MOS | Coil, magnetic resonance, specialty | 2 | BM Contour L Coil set 0.55T | ||
| 11 | 04056869259802 | 11461857 | syngo.via VB50A Medical Device Identifier | LLZ | System, image processing, radiological | 2 | syngo.via | |
| 12 | 04056869247953 | 11368091 | syngo.via VB40A USB Media Virtual Container (Package) | LLZ | System, image processing, radiological | 2 | syngo.via | |
| 13 | 04056869237633 | 11461436 | syngo.via VB40A Medical Device Identifier | LLZ | System, image processing, radiological | 2 | syngo.via | |
| 14 | 04056869154992 | 11107444 | IZL | System, x-ray, mobile | 2 | MOBILETT Elara Max | ||
| 15 | 04056869149325 | 11327700 | JAK,IZI,OWB,JAA | System, x-ray, tomography, computed,System, x-ray, angiographic,Interventional f System, x-ray, tomography, computed,System, x-ray, angiographic,Interventional fluoroscopic x-ray system,System, x-ray, fluoroscopic, image-intensified | 2 | ARTIS icono floor | ||
| 16 | 04056869123646 | 11299058 | syngo.via VB30 Medical Device Identifier | LLZ | System, image processing, radiological | 2 | syngo.via | |
| 17 | 04056869106212 | 11299040 | syngo.via VB20A "Stock Keeping Unit B" - product label DVD Media Cover "HF02": U syngo.via VB20A "Stock Keeping Unit B" - product label DVD Media Cover "HF02": Unit contains following registered Medical Devices:(1)syngo.via -GTIN 04056869040134;(2)syngo.interventional -GTIN 04056869026305;(3) syngo.CT Coronary Analysis - GTIN 04056869026329;(4)syngo.CT Cardiac Function -GTIN 04056869026336;(5)syngo.CT CaScoring -GTIN 04056869026343;(6) syngo.CT Vascular Analysis -GTIN04056869026350;(7)syngo.CT Colonography -GTIN 04056869026367;(8)syngo.CT Pulmo3D -GTIN 04056869026374;(9)syng | LLZ | System, image processing, radiological | 2 | syngo.via | |
| 18 | 04056869084725 | 11299019 | syngo.via VB20A "Stock Keeping Unit C" - packaging label "HF02": This unit conta syngo.via VB20A "Stock Keeping Unit C" - packaging label "HF02": This unit contains the following registered Medical Devices:(1)syngo.via -GTIN 04056869040134;(2)syngo.interventional -GTIN 04056869026305;(3) syngo.CT Coronary Analysis - GTIN 04056869026329;(4)syngo.CT Cardiac Function -GTIN 04056869026336;(5)syngo.CT CaScoring -GTIN 04056869026343;(6) syngo.CT Vascular Analysis -GTIN04056869026350;(7)syngo.CT Colonography -GTIN 04056869026367;(8)syngo.CT Pulmo3D -GTIN 04056869026374;(9)syngo.CT | LLZ | System, image processing, radiological | 2 | syngo.via | |
| 19 | 04056869054964 | 11298722 | syngo.via VB20A "Stock Keeping Unit C" - packaging label: This unit contains the syngo.via VB20A "Stock Keeping Unit C" - packaging label: This unit contains the following registered Medical Devices:(1)syngo.via -GTIN 04056869040134;(2)syngo.interventional -GTIN 04056869026305;(3) syngo.CT Coronary Analysis - GTIN 04056869026329;(4)syngo.CT Cardiac Function -GTIN 04056869026336;(5)syngo.CT CaScoring -GTIN 04056869026343;(6) syngo.CT Vascular Analysis -GTIN04056869026350;(7)syngo.CT Colonography -GTIN 04056869026367;(8)syngo.CT Pulmo3D -GTIN 04056869026374;(9)syngo.CT Neuro D | LLZ | System, image processing, radiological | 2 | syngo.via | |
| 20 | 04056869054957 | 11298712 | syngo.via VB20A "Stock Keeping Unit B" - product label DVD Media Cover: This uni syngo.via VB20A "Stock Keeping Unit B" - product label DVD Media Cover: This unit contains the following registered Medical Devices:(1)syngo.via -GTIN 04056869040134;(2)syngo.interventional -GTIN 04056869026305;(3) syngo.CT Coronary Analysis - GTIN 04056869026329;(4)syngo.CT Cardiac Function -GTIN 04056869026336;(5)syngo.CT CaScoring -GTIN 04056869026343;(6) syngo.CT Vascular Analysis -GTIN04056869026350;(7)syngo.CT Colonography -GTIN 04056869026367;(8)syngo.CT Pulmo3D -GTIN 04056869026374;(9)sy | LLZ | System, image processing, radiological | 2 | syngo.via | |
| 21 | 04056869053196 | 10561700 | JAK | System, x-ray, tomography, computed | 2 | syngo.CT View&GO | ||
| 22 | 04056869044651 | 11105252 | LLZ | System, image processing, radiological | 2 | syngo.Breast Care | ||
| 23 | 04056869040134 | 11298680 | syngo.via VB20A product label - about box | LLZ | System, image processing, radiological | 2 | syngo.via | |
| 24 | 04056869033686 | 11298690 | syngo.via VA30B "Stock Keeping Unit B" - product label DVD Media Cover: This uni syngo.via VA30B "Stock Keeping Unit B" - product label DVD Media Cover: This unit contains the following registered Medical Devices:(1) syngo.via GTIN 04056869020976 (2) syngo.interventional GTIN 04056869020501 (3) syngo.CT Coronary Analysis GTIN 04056869007762(4) syngo.CT Cardiac Function - GTIN 04056869007779 (5) syngo.CT CaScoring - GTIN 04056869007786 (6) syngo.CT Vascular AnalysisGTIN 04056869007793 (7) syngo.CT Colonography - GTIN 04056869007809 (8) syngo.CT Pulmo3D - GTIN 04056869007816 ( | LLZ | System, image processing, radiological | 2 | syngo.via | |
| 25 | 04056869033679 | 11298689 | syngo.via VA30B "Stock Keeping Unit C" - packaging label This unit contains the syngo.via VA30B "Stock Keeping Unit C" - packaging label This unit contains the following registered Medical Devices:(1) syngo.via - GTIN 04056869020976 (2) syngo.interventional - GTIN 04056869020501(3) syngo.CT Coronary Analysis - GTIN 4056869007762 (4) syngo.CTCardiac Function - GTIN 04056869007779 (5) syngo.CT CaScoring - GTIN 04056869007786 (6) syngo.CT Vascular Analysis -- GTIN 04056869007793 (7) syngo.CT Colonography - GTIN 04056869007809 (8) syngo.CT Pulmo3D - GTIN 04056869007816 (9) syng | LLZ | System, image processing, radiological | 2 | syngo.via | |
| 26 | 04056869020976 | 11250093 | "syngo.via VA30B product label - about box" | LLZ | System, image processing, radiological | 2 | syngo.via | |
| 27 | 04056869023083 | 10835464 | contains Medical Device Mat.: 10835689 (GTIN: 04056869044699) | LNH,LNI,MOS | System, nuclear magnetic resonance imaging,System, nuclear magnetic resonance sp System, nuclear magnetic resonance imaging,System, nuclear magnetic resonance spectroscopic,Coil, magnetic resonance, specialty | 2 | Spine 32 RS coil kit 3T | |
| 28 | 04056869020891 | 11250065 | syngo.via VB10B"Stock Keeping Unit C"- packaging labelThis unit contains the fol syngo.via VB10B"Stock Keeping Unit C"- packaging labelThis unit contains the following registered Medical Devices:(1) syngo.via - GTIN 04056869007045(2) syngo.interventional - GTIN 04056869020518(3) syngo.CT Coronary Analysis - GTIN 04056869013855(4) syngo.CT Cardiac Function - GTIN 04056869013862(5) syngo.CT CaScoring - GTIN 04056869013879(6) syngo.CT Vascular Analysis - GTIN 04056869013886(7) syngo.CT Colonography - GTIN 04056869013893(8) syngo.CT Pulmo3D - GTIN 04056869013909(9) syngo.CT Neur | LLZ | System, image processing, radiological | 2 | syngo.via | |
| 29 | 04056869020884 | 11250036 | syngo.via VB10B"Stock Keeping Unit B" - product label DVD Media CoverThis unit c syngo.via VB10B"Stock Keeping Unit B" - product label DVD Media CoverThis unit contains the following registered Medical Devices:(1) syngo.via - GTIN 04056869007045(2) syngo.interventional - GTIN 04056869020518(3) syngo.CT Coronary Analysis - GTIN 04056869013855(4) syngo.CT Cardiac Function - GTIN 04056869013862(5) syngo.CT CaScoring - GTIN 04056869013879(6) syngo.CT Vascular Analysis - GTIN 04056869013886(7) syngo.CT Colonography - GTIN 04056869013893(8) syngo.CT Pulmo3D - GTIN 04056869013909(9 | LLZ | System, image processing, radiological | 2 | syngo.via | |
| 30 | 04056869015484 | 10835455 | Contains Medical Device Mat. 10835446 (GTIN:04056869015460) | LNI,LNH,MOS | System, nuclear magnetic resonance spectroscopic,System, nuclear magnetic resona System, nuclear magnetic resonance spectroscopic,System, nuclear magnetic resonance imaging,Coil, magnetic resonance, specialty | 2 | Body 30 MR coil set 3T | |
| 31 | 04056869014883 | 10496530 | MRI Coil | LNH,MOS,LNI | System, nuclear magnetic resonance imaging,Coil, magnetic resonance, specialty,S System, nuclear magnetic resonance imaging,Coil, magnetic resonance, specialty,System, nuclear magnetic resonance spectroscopic | 2 | Body 18 MR Coil 1.5T | |
| 32 | 04056869014777 | 10185549 | Contains Medical Device Mat. 10606491 (GTIN:04056869015125) | OUO | Tomographic imager combining emission computed tomography with nuclear magnetic resonance | 2 | mMR Spine Matrix coil set | |
| 33 | 04056869014746 | 10185545 | Contains Medical Device Mat. 10496545 (GTIN:04056869014937) | LNI,LNH,MOS | System, nuclear magnetic resonance spectroscopic,System, nuclear magnetic resona System, nuclear magnetic resonance spectroscopic,System, nuclear magnetic resonance imaging,Coil, magnetic resonance, specialty | 2 | Spine 32 MR Coil set 3T 098 | |
| 34 | 04056869014722 | 10185543 | Contains Medical Device Mat. 10496543 (GTIN:04056869014913) | LNI,MOS,LNH | System, nuclear magnetic resonance spectroscopic,Coil, magnetic resonance, speci System, nuclear magnetic resonance spectroscopic,Coil, magnetic resonance, specialty,System, nuclear magnetic resonance imaging | 2 | PA 36 MR coil set 3T 098 | |
| 35 | 04056869014616 | 10185502 | Contains Medical Device Mat.10185552 (GTIN:04056869014784) | LNH,MOS,LNI | System, nuclear magnetic resonance imaging,Coil, magnetic resonance, specialty,S System, nuclear magnetic resonance imaging,Coil, magnetic resonance, specialty,System, nuclear magnetic resonance spectroscopic | 2 | Flex large 4 MR coil set 1.5T | |
| 36 | 04056869014418 | 08626553 | Contains Medical Device Mat. 8622644 (GTIN:04056869014296) | LNH | System, nuclear magnetic resonance imaging | 2 | 3T Head Matrix MR coil kit | |
| 37 | 04056869014371 | 08625720 | MRI Coil | MOS,LNI,OUO,LNH | Coil, magnetic resonance, specialty,System, nuclear magnetic resonance spectrosc Coil, magnetic resonance, specialty,System, nuclear magnetic resonance spectroscopic,Tomographic imager combining emission computed tomography with nuclear magnetic resonance,System, nuclear magnetic resonance imaging | 2 | 3T Loop 4 cm MR coil | |
| 38 | 04056869014357 | 08625662 | MRI Coil | LNH,LNI,OUO,MOS | System, nuclear magnetic resonance imaging,System, nuclear magnetic resonance sp System, nuclear magnetic resonance imaging,System, nuclear magnetic resonance spectroscopic,Tomographic imager combining emission computed tomography with nuclear magnetic resonance,Coil, magnetic resonance, specialty | 2 | 3T Loop 11cm MR coil | |
| 39 | 04056869014180 | 07575256 | Contains Medical Device Mat. 7579472 (GTIN:04056869014265) | LNI,MOS,LNH | System, nuclear magnetic resonance spectroscopic,Coil, magnetic resonance, speci System, nuclear magnetic resonance spectroscopic,Coil, magnetic resonance, specialty,System, nuclear magnetic resonance imaging | 2 | CP EXTREMITY MR COIL KIT | |
| 40 | 04056869011554 | 10092611 | KPW | Device, beam limiting, x-ray, diagnostic | 2 | Collimator ML01 II | ||
| 41 | 04056869010144 | 10764562 | DQK | COMPUTER, DIAGNOSTIC, PROGRAMMABLE | 2 | Sensis Lite | ||
| 42 | 04056869008981 | 10762473 | Diagnostic Urology | JAA | System, x-ray, fluoroscopic, image-intensified | 2 | Uroskop Omnia Max | |
| 43 | 04056869008912 | 04779695 | JAK | System, x-ray, tomography, computed | 2 | Mat for patient table | ||
| 44 | 04056869008899 | 04779588 | JAK | System, x-ray, tomography, computed | 2 | TransX | ||
| 45 | 04056869008875 | 04779273 | JAK | System, x-ray, tomography, computed | 2 | Osteo-CT Plus4/VZ | ||
| 46 | 04056869008783 | 08096864 | JAK | System, x-ray, tomography, computed | 2 | Mattress with flat surface cpl. | ||
| 47 | 04056869008684 | 10187332 | JAK | System, x-ray, tomography, computed | 2 | Slide board MPT3 | ||
| 48 | 04056869008677 | 08096716 | JAK | System, x-ray, tomography, computed | 2 | Mattress | ||
| 49 | 04056869008622 | 07445682 | JAK | System, x-ray, tomography, computed | 2 | Head rest 15 degree for head support | ||
| 50 | 04056869008615 | 07445674 | JAK | System, x-ray, tomography, computed | 2 | Cushion Set |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | B159MEDSTREAMINGPACS0 | Medstreaming | Medstreaming PACS | FIVOS, INC. | ||
| 2 | B159FIVOSPACS0 | 5 | Fivos PACS | FIVOS, INC. | ||
| 3 | B148WSONE1910 | 1.9.1 | WorkstationOne is a vendor-neutral diagnostic breast imaging workstation which c WorkstationOne is a vendor-neutral diagnostic breast imaging workstation which consists of a software system that obtains breast imaging screening or diagnosis exams from PACS (Picture Archiving and Communication System) or Modalities; displays and manipulates the images for radiologists to perform interpretation task. The workstation can also interface with a reporting system to generate an interpretation report. Optionally, the workstation supports media exchange and film printing. | WorkstationOne™ | THREE PALM SOFTWARE | |
| 4 | B148WSONE1900 | 1.9.0 | WorkstationOne is a vendor-neutral diagnostic breast imaging workstation which c WorkstationOne is a vendor-neutral diagnostic breast imaging workstation which consists of a software system that obtains breast imaging screening or diagnosis exams from PACS (Picture Archiving and Communication System) or Modalities; displays and manipulates the images for radiologists to perform interpretation task. The workstation can also interface with a reporting system to generate an interpretation report. Optionally, the workstation supports media exchange and film printing. | WorkstationOne™ | THREE PALM SOFTWARE | |
| 5 | B148WSONE1890 | 1.8.9 | WorkstationOne is a vendor-neutral diagnostic breast imaging workstation which c WorkstationOne is a vendor-neutral diagnostic breast imaging workstation which consists of a software system that obtains breast imaging screening or diagnosis exams from PACS (Picture Archiving and Communication System) or Modalities; displays and manipulates the images for radiologists to perform interpretation task. The workstation can also interface with a reporting system to generate an interpretation report. Optionally, the workstation supports media exchange and film printing. | WorkstationOne™ | THREE PALM SOFTWARE | |
| 6 | B148WSONE1880 | 1.8.8 | WorkstationOne is a vendor-neutral diagnostic breast imaging workstation which c WorkstationOne is a vendor-neutral diagnostic breast imaging workstation which consists of a software system that obtains breast imaging screening or diagnosis exams from PACS (Picture Archiving and Communication System) or Modalities; displays and manipulates the images for radiologists to perform interpretation task. The workstation can also interface with a reporting system to generate an interpretation report. Optionally, the workstation supports media exchange and film printing. | WorkstationOne™ | THREE PALM SOFTWARE | |
| 7 | B148WSONE1870 | 1.8.7 | WorkstationOne is a vendor-neutral diagnostic breast imaging workstation which c WorkstationOne is a vendor-neutral diagnostic breast imaging workstation which consists of a software system that obtains breast imaging screening or diagnosis exams from PACS (Picture Archiving and Communication System) or Modalities; displays and manipulates the images for radiologists to perform interpretation task. The workstation can also interface with a reporting system to generate an interpretation report. Optionally, the workstation supports media exchange and film printing. | WorkstationOne™ | THREE PALM SOFTWARE | |
| 8 | B148WSONE1860 | 1.8.6 | WorkstationOne is a vendor-neutral diagnostic breast imaging workstation which c WorkstationOne is a vendor-neutral diagnostic breast imaging workstation which consists of a software system that obtains breast imaging screening or diagnosis exams from PACS (Picture Archiving and Communication System) or Modalities; displays and manipulates the images for radiologists to perform interpretation task. The workstation can also interface with a reporting system to generate an interpretation report. Optionally, the workstation supports media exchange and film printing. | WorkstationOne™ | THREE PALM SOFTWARE | |
| 9 | B148WSONE1850 | 1.8.5 | WorkstationOne is a vendor-neutral diagnostic breast imaging workstation which c WorkstationOne is a vendor-neutral diagnostic breast imaging workstation which consists of a software system that obtains breast imaging screening or diagnosis exams from PACS (Picture Archiving and Communication System) or Modalities; displays and manipulates the images for radiologists to perform interpretation task. The workstation can also interface with a reporting system to generate an interpretation report. Optionally, the workstation supports media exchange and film printing. | WorkstationOne™ | THREE PALM SOFTWARE | |
| 10 | B148WSONE1840 | 1.8.4 | WorkstationOne is a vendor-neutral diagnostic breast imaging workstation which c WorkstationOne is a vendor-neutral diagnostic breast imaging workstation which consists of a software system that obtains breast imaging screening or diagnosis exams from PACS (Picture Archiving and Communication System) or Modalities; displays and manipulates the images for radiologists to perform interpretation task. The workstation can also interface with a reporting system to generate an interpretation report. Optionally, the workstation supports media exchange and film printing. | WorkstationOne™ | THREE PALM SOFTWARE | |
| 11 | B148WSONE1830 | 1.8.3 | WorkstationOne is a vendor-neutral diagnostic breast imaging workstation which c WorkstationOne is a vendor-neutral diagnostic breast imaging workstation which consists of a software system that obtains breast imaging screening or diagnosis exams from PACS (Picture Archiving and Communication System) or Modalities; displays and manipulates the images for radiologists to perform interpretation task. The workstation can also interface with a reporting system to generate an interpretation report. Optionally, the workstation supports media exchange and film printing. | WorkstationOne™ | THREE PALM SOFTWARE | |
| 12 | B148WSONE1820 | 1.8.2 | WorkstationOne is a vendor-neutral diagnostic breast imaging workstation which c WorkstationOne is a vendor-neutral diagnostic breast imaging workstation which consists of a software system that obtains breast imaging screening or diagnosis exams from PACS (Picture Archiving and Communication System) or Modalities; displays and manipulates the images for radiologists to perform interpretation task. The workstation can also interface with a reporting system to generate an interpretation report. Optionally, the workstation supports media exchange and film printing. | WorkstationOne™ | THREE PALM SOFTWARE | |
| 13 | B148WSONE1810 | 1.8.1 | WorkstationOne is a vendor-neutral diagnostic breast imaging workstation which c WorkstationOne is a vendor-neutral diagnostic breast imaging workstation which consists of a software system that obtains breast imaging screening or diagnosis exams from PACS (Picture Archiving and Communication System) or Modalities; displays and manipulates the images for radiologists to perform interpretation task. The workstation can also interface with a reporting system to generate an interpretation report. Optionally, the workstation supports media exchange and film printing. | WorkstationOne™ | THREE PALM SOFTWARE | |
| 14 | B141QANGIOXA730 | 7.3 | QAngio XA is image post-processing software for the viewing and quantification o QAngio XA is image post-processing software for the viewing and quantification of digital x-ray angiographic images of blood vessels and of the chambers of the heart. Semi-automatic contour detection forms the basis for the analyses. Its functionality is independent of the type of vendor acquisition equipment. The analysis results are available on screen, and can be exported in various electronic formats. QAngio XA has been developed as a standalone application to run on a Windows based operating system. The import of images and the export of analysis results are via CD / DVD, a PACS or network environment.QAngio XA comprises functionalities for analyzing the blood vessels and the left ventricle, the right ventricle, stent and sub-segments, coronary aneurysms, and bifurcations. | QAngio XA | MEDIS MEDICAL IMAGING SYSTEMS B.V. | |
| 15 | B141MEDISSUITEXA2D20190 | 2019 | Medis Suite XA is software intended to be used for performing calculations in X- Medis Suite XA is software intended to be used for performing calculations in X-ray angiographic images of the chambers of the heart and of blood vessels. These calculations are based on contours that are either manually drawn by the clinician or trained medical technician who is operating the software, or automatically detected by the software and subsequently presented for review and manual editing. Medis Suite XA is also intended to be used for performing caliper measurements. The results obtained are displayed on top of the images and provided in reports.The analysis results obtained with Medis Suite XA are intended for use by cardiologists and radiologists:• to support clinical decisions concerning the heart and vessels• to support the evaluation of interventions or drug therapy applied for conditions of the heart and vessels | Medis Suite XA 2D | MEDIS MEDICAL IMAGING SYSTEMS B.V. | |
| 16 | B141MEDISSUITEXA2D20180 | 2018 | Medis Suite XA is software intended to be used for performing calculations in X- Medis Suite XA is software intended to be used for performing calculations in X-ray angiographic images of the chambers of the heart and of blood vessels. These calculations are based on contours that are either manually drawn by the clinician or trained medical technician who is operating the software, or automatically detected by the software and subsequently presented for review and manual editing. Medis Suite XA is also intended to be used for performing caliper measurements. The results obtained are displayed on top of the images and provided in reports.The analysis results obtained with Medis Suite XA are intended for use by cardiologists and radiologists:• to support clinical decisions concerning the heart and vessels• to support the evaluation of interventions or drug therapy applied for conditions of the heart and vessels | Medis Suite XA 2D | MEDIS MEDICAL IMAGING SYSTEMS B.V. | |
| 17 | B141MEDISSUITEXA20220 | 2022 | Medis Suite XA 2022 is indicated for use in clinical settings where validated an Medis Suite XA 2022 is indicated for use in clinical settings where validated and reproducible quantified results are needed to support the calculations in X-ray angiographic images of the chambers of the heart and of blood vessels, for use on individual patients with cardiovascular disease. When the quantified results provided by Medis Suite XA 2022 are used in a clinical setting on X-ray images of an individual patient, they can be used to support the clinical decisions making for the diagnosis of the patient or the evaluation of the treatment applied. In this case, the results are explicitly not to be regarded as the sole, irrefutable basis for clinical diagnosis, and they are only intended for use by the responsible clinicians. | Medis Suite XA | MEDIS MEDICAL IMAGING SYSTEMS B.V. | |
| 18 | B141MEDISSUITEXA20210 | 2021 | Medis Suite XA is indicated for use in clinical settings where validated and rep Medis Suite XA is indicated for use in clinical settings where validated and reproducible quantified results are needed to support the calculations in X-ray angiographic images of the chambers of the heart and of blood vessels, for use on individual patients with cardiovascular disease. When the quantified results provided by Medis Suite XA are used in a clinical setting on X-ray images of an individual patient, they can be used to support the clinical decisions making for the diagnosis of the patient or the evaluation of the treatment applied. In this case, the results are explicitly not to be regarded as the sole, irrefutable basis for clinical diagnosis, and they are only intended for use by the responsible clinicians. | Medis Suite XA | MEDIS MEDICAL IMAGING SYSTEMS B.V. | |
| 19 | B141MEDISSUITEXA20200 | 2020 | Medis Suite XA is indicated for use in clinical settings where validated and rep Medis Suite XA is indicated for use in clinical settings where validated and reproducible quantified results are needed to support the calculations in X-ray angiographic images of the chambers of the heart and of blood vessels, for use on individual patients with cardiovascular disease. XA2D: When the quantified results provided by Medis Suite XA is used in a clinical setting on X-ray images of an individual patient, they can be used to support the clinical decisions making for the diagnosis of the patient or the evaluation of the treatment applied. In this case, the results are explicitly not to be regarded as the sole, irrefutable basis for clinical diagnosis, and they are only intended for use by the responsible clinicians.XA3D: When the quantified results provided by Medis Suite XA is used in a clinical setting on X-ray images of an individual patient, the results are only intended for use by the responsible clinicians. | Medis Suite XA | MEDIS MEDICAL IMAGING SYSTEMS B.V. | |
| 20 | B141MEDISSUITEXA20190 | 2.0 | QANGIO XA 3D is software intended to be used for performing calculations in X-ra QANGIO XA 3D is software intended to be used for performing calculations in X-ray angiographic images of the coronary arteries. QANGIO XA 3D enables interventional cardiologists and researchers to obtain quantifications of one or more lesions in the analyzed coronary vessel segment. In particular, QANGIO XA 3D provides:• Quantitative results of coronary vessel segments based on a 3D reconstructed model;• Dimensions of the cardiovascular vessels and lesions;• Quantification of the pressure drop in coronary vessels. | QAngio XA 3D | MEDIS MEDICAL IMAGING SYSTEMS B.V. | |
| 21 | B141MEDISSUITEMRCT300 | 3.0 | Medis Suite MRCT is software intended to be used for the visualization and analy Medis Suite MRCT is software intended to be used for the visualization and analysis of MR and CT images of the heart and blood vessels. Medis Suite MRCT is intended to support the following visualization functionalities:- cine loop and 2D review- double oblique review- 3D review by means of MIP and volume rendering- 3D reformatting - performing caliper measurements Medis Suite MRCT is also intended to support the following analyses:- cardiac function quantification- MR velocity-encoded flow quantification- anatomy and tissue segmentation - signal intensity analysis for the myocardium and infarct sizing- MR parametric maps (such as T1, T2, T2* relaxation)Medis Suite MRCT is also intended to be used for:- quantification of T2* results in MR images that can be used to characterize iron loading in the heart and the liver- MR velocity-encoded flow quantification of cerebral spinal fluidThese analyses are based on contours that are either manually drawn by the clinician or trained medical technician who is operating the software, or automatically detected by the software and subsequently presented for review and manual editing. The results obtained are displayed on top of the images and provided in reports.The analysis results obtained with Medis Suite MRCT are intended for use by cardiologists and radiologists to support clinical decisions concerning the heart and vessels. | Medis Suite MRCT | MEDIS MEDICAL IMAGING SYSTEMS B.V. | |
| 22 | B141MEDISSUITEMRCT210 | 2.1 | Medis Suite MRCT is software intended to be used for the visualization and analy Medis Suite MRCT is software intended to be used for the visualization and analysis of MR and CT images of the heart and blood vessels. This includes:- double oblique review of MR Angiographic images,- 3D review by means of MIP and volume rendering,- 3D reformatting of MR Angiographic images, and- performing caliper measurements. Medis Suite MRCT is intended to support the following visualization functionalities:- cine loop and 2D review- performing caliper measurements Medis Suite MRCT is also intended to support the following analyses:- cardiac function quantification- anatomy and tissue segmentation - signal intensity analysis for the myocardium and infarct sizing- MR parametric maps (such as T1, T2, T2* relaxation)- MR velocity-encoded flow quantificationMedis Suite MRCT is also intended to be used for:- quantification of T2* results in MR images that can be used to characterize iron loading in the heart and the liver - MR velocity-encoded flow quantification of cerebral spinal fluidThese analyses are based on contours that are either manually drawn by the clinician or trained medical technician who is operating the software, or automatically detected by the software and subsequently presented for review and manual editing. The results obtained are displayed on top of the images and provided in reports.The analysis results obtained with Medis Suite MRCT are intended for use by cardiologists and radiologists:- to support clinical decisions concerning the heart and vessels, and- to support the evaluation of interventions or drug therapy applied for conditions of the heart and vessels. | Medis Suite MRCT | MEDIS MEDICAL IMAGING SYSTEMS B.V. | |
| 23 | B141MEDISSUITEMRCT20220 | 2022 | Medis Suite MRCT 2022 is indicated for use in clinical settings where more repro Medis Suite MRCT 2022 is indicated for use in clinical settings where more reproducible than manually derived quantified results are needed to support the visualization and analysis of MR and CT images of the heart and blood vessels for use on individual patients with cardiovascular disease. Further, Medis Suite MRCT 2022 allows the quantification of T2* in MR images of the heart and the liver. Finally, Medis Suite MRCT 2022 can be used for the quantification of cerebral spinal fluid in MR velocity-encoded flow images. When the quantified results provided by Medis Suite MRCT 2022 are used in a clinical setting on MR and CT images of an individual patient, they can be used to support the clinical decision making for the diagnosis of the patient. In this case, the results are explicitly not to be regarded as the sole, irrefutable basis for clinical diagnosis, and they are only intended for use by the responsible clinicians. | Medis Suite MRCT | MEDIS MEDICAL IMAGING SYSTEMS B.V. | |
| 24 | B141MEDISSUITEMRCT20210 | 2021 | Medis Suite MRCT 2021 is indicated for use in clinical settings where more repro Medis Suite MRCT 2021 is indicated for use in clinical settings where more reproducible than manually derived quantified results are needed to support the visualization and analysis of MR and CT images of the heart and blood vessels for use on individual patients with cardiovascular disease. Further, Medis Suite MRCT 2021 allows the quantification of T2* in MR images of the heart and the liver. Finally, Medis Suite MRCT 2021 can be used for the quantification of cerebral spinal fluid in MR velocity-encoded flow images. When the quantified results provided by Medis Suite MRCT 2021 are used in a clinical setting on MR and CT images of an individual patient, they can be used to support the clinical decision making for the diagnosis of the patient. In this case, the results are explicitly not to be regarded as the sole, irrefutable basis for clinical diagnosis, and they are only intended for use by the responsible clinicians. | Medis Suite MRCT | MEDIS MEDICAL IMAGING SYSTEMS B.V. | |
| 25 | B141MEDISSUITEMRCT20200 | 2020 | Medis Suite MRCT is indicated for use in clinical settings where more reproducib Medis Suite MRCT is indicated for use in clinical settings where more reproducible than manually derived quantified results are needed to support the visualization and analysis of MR and CT images of the heart and blood vessels for use on individual patients with cardiovascular disease. Further, Medis Suite MRCT allows the quantification of T2* in MR images of the heart and the liver. Finally, Medis Suite MRCT can be used for the quantification of cerebral spinal fluid in MR velocity-encoded flow images. When the quantified results provided by Medis Suite MRCT 2020 are used in a clinical setting on MR and CT images of an individual patient, they can be used to support the clinical decision making for the diagnosis of the patient. In this case, the results are explicitly not to be regarded as the sole, irrefutable basis for clinical diagnosis, and they are only intended for use by the responsible clinicians. | Medis Suite MRCT | MEDIS MEDICAL IMAGING SYSTEMS B.V. | |
| 26 | B141MEDISSUITEMRCT20190 | 2019 | Medis Suite MRCT is indicated for use in clinical settings where more reproducib Medis Suite MRCT is indicated for use in clinical settings where more reproducible than manually derived quantified results are needed to support the visualization and analysis of MR and CT images of the heart and blood vessels for use on individual patients with cardiovascular disease. Further, Medis Suite MRCT allows the quantification of T2* in MR images of the heart and the liver. Finally, Medis Suite MRCT can be used for the quantification of cerebral spinal fluid in MR velocity-encoded flow images. When the quantified results provided by Medis Suite MRCT are used in a clinical setting on MR and CT images of an individual patient, they can be used to support the clinical decision making for the diagnosis of the patient. In this case, the results are explicitly not to be regarded as the sole, irrefutable basis for clinical diagnosis, and they are only intended for use by the responsible clinicians. | Medis Suite MRCT | MEDIS MEDICAL IMAGING SYSTEMS B.V. | |
| 27 | B141MEDISSUITEMRCT20180 | 2018 | Medis Suite MRCT is software intended to be used for the visualization and analy Medis Suite MRCT is software intended to be used for the visualization and analysis of MR and CT images of the heart and blood vessels. Medis Suite MRCT is intended to support the following visualization functionalities:- cine loop and 2D review- double oblique review- 3D review by means of MIP and volume rendering- 3D reformatting - performing caliper measurements Medis Suite MRCT is also intended to support the following analyses:- cardiac function quantification- MR velocity-encoded flow quantification- anatomy and tissue segmentation - signal intensity analysis for the myocardium and infarct sizing- MR parametric maps (such as T1, T2, T2* relaxation)Medis Suite MRCT is also intended to be used for:- quantification of T2* results in MR images that can be used to characterize iron loading in the heart and the liver- MR velocity-encoded flow quantification of cerebral spinal fluidThese analyses are based on contours that are either manually drawn by the clinician or trained medical technician who is operating the software, or automatically detected by the software and subsequently presented for review and manual editing. The results obtained are displayed on top of the images and provided in reports.The analysis results obtained with Medis Suite MRCT are intended for use by cardiologists and radiologists to support clinical decisions concerning the heart and vessels. | Medis Suite MRCT | MEDIS MEDICAL IMAGING SYSTEMS B.V. | |
| 28 | B131ZIOE1001SYS0P | 2.4.3.1 | ZIOE1001SYS | A self-standing software program that adds specific image processing and/or anal A self-standing software program that adds specific image processing and/or analysis capabilities to radiological DICOM image data. | Ziostation | QI IMAGING LLC |
| 29 | B127WP90 | 9 | n/a | WebPAX® is intended for use in the communication and storage of medical images. WebPAX® is intended for use in the communication and storage of medical images. WebPAX® is alsointended for use as a comprehensive solution to view, optimize, and post-process diagnostic medicalimages as an aid to physicians and other healthcare professionals in the evaluation of digital imagingexaminations. | WebPAX® | HEART IMAGING TECHNOLOGIES, LLC |
| 30 | B119PREVIEW0 | 4.x | Preview Treatment Planning Software | M2S, INC. | ||
| 31 | B109OPENSIGHT188040 | OpenSight 1.8804 | OpenSight is the combination of augmented reality glasses and Novarad's medical OpenSight is the combination of augmented reality glasses and Novarad's medical imaging software to create three-dimensional holograms of scanned images from different modalities including CR, DX, CT, MR, and PT. | OpenSight | NOVARAD CORPORATION | |
| 32 | B109OPENSIGHT187060 | OpenSight 1.8706 | OpenSight is the combination of augmented reality glasses and Novarad's medical OpenSight is the combination of augmented reality glasses and Novarad's medical imaging software to create three-dimensional holograms of scanned images from different modalities including CR, DX, CT, MR, and PT. | OpenSight | NOVARAD CORPORATION | |
| 33 | B109OPENSIGHT180760 | OpenSight 1.8076 | OpenSight is the combination of augmented reality glasses and Novarad's medical OpenSight is the combination of augmented reality glasses and Novarad's medical imaging software to create three-dimensional holograms of scanned images from different modalities including CR, DX, CT, MR, and PT. | OpenSight | NOVARAD CORPORATION | |
| 34 | B109NOVAPACS8930 | NovaPACS 8.9.3 | A picture archiving and communication system software that retrieves, archives, A picture archiving and communication system software that retrieves, archives, distributes, and displays images and data from all common modalities. | NovaPACS | NOVARAD CORPORATION | |
| 35 | B109NOVAPACS8920 | NovaPACS 8.9.2 | A picture archiving and communication system software that retrieves, archives, A picture archiving and communication system software that retrieves, archives, distributes, and displays images and data from all common modalities. | NovaPACS | NOVARAD CORPORATION | |
| 36 | B109NOVAPACS8910 | NovaPACS 8.9.1 | A picture archiving and communication system software that retrieves, archives, A picture archiving and communication system software that retrieves, archives, distributes, and displays images and data from all common modalities. | NovaPACS | NOVARAD CORPORATION | |
| 37 | B109NOVAPACS8850 | NovaPACS 8.8.5 | A picture archiving and communication system software that retrieves, archives, A picture archiving and communication system software that retrieves, archives, distributes, and displays images and data from all common modalities. | NovaPACS | NOVARAD CORPORATION | |
| 38 | B109NOVAPACS8840 | NovaPACS 8.8.4 | A picture archiving and communication system software that retrieves, archives, A picture archiving and communication system software that retrieves, archives, distributes, and displays images and data from all common modalities. | NovaPACS | NOVARAD CORPORATION | |
| 39 | B109NOVAPACS8830 | NovaPACS 8.8.3 | A picture archiving and communication system software that retrieves, archives, A picture archiving and communication system software that retrieves, archives, distributes, and displays images and data from all common modalities. | NovaPACS | NOVARAD CORPORATION | |
| 40 | B109NOVAPACS8780 | NovaPACS 8.7.8 | A picture archiving and communication system software that retrieves, archives, A picture archiving and communication system software that retrieves, archives, distributes, and displays images and data from all common modalities. | NovaPACS | NOVARAD CORPORATION | |
| 41 | B109NOVAPACS8770 | NovaPACS 8.7.7 | A picture archiving and communication system software that retrieves, archives, A picture archiving and communication system software that retrieves, archives, distributes, and displays images and data from all common modalities. | NovaPACS | NOVARAD CORPORATION | |
| 42 | B109NOVAPACS8760 | NovaPACS 8.7.6 | A picture archiving and communication system software that retrieves, archives, A picture archiving and communication system software that retrieves, archives, distributes, and displays images and data from all common modalities. | NovaPACS | NOVARAD CORPORATION | |
| 43 | B109NOVAPACS8740 | NovaPACS 8.7.4 | A picture archiving and communication system software that retrieves, archives, A picture archiving and communication system software that retrieves, archives, distributes, and displays images and data from all common modalities. | NovaPACS | NOVARAD CORPORATION | |
| 44 | B109NOVAPACS87110 | NovaPACS 8.7.11 | A picture archiving and communication system software that retrieves, archives, A picture archiving and communication system software that retrieves, archives, distributes, and displays images and data from all common modalities. | NovaPACS | NOVARAD CORPORATION | |
| 45 | B109NOVAPACS8690 | NovaPACS 8.6.9 | A picture archiving and communication system software that retrieves, archives, A picture archiving and communication system software that retrieves, archives, distributes, and displays images and data from all common modalities. | NovaPACS | NOVARAD CORPORATION | |
| 46 | B109NOVAPACS8680 | NovaPACS 8.6.8 | A picture archiving and communication system software that retrieves, archives, A picture archiving and communication system software that retrieves, archives, distributes, and displays images and data from all common modalities. | NovaPACS | NOVARAD CORPORATION | |
| 47 | B109NOVAPACS8670 | NovaPACS 8.6.7 | A picture archiving and communication system software that retrieves, archives, A picture archiving and communication system software that retrieves, archives, distributes, and displays images and data from all common modalities. | NovaPACS | NOVARAD CORPORATION | |
| 48 | B109NOVAPACS8660 | NovaPACS 8.6.6 | A picture archiving and communication system software that retrieves, archives, A picture archiving and communication system software that retrieves, archives, distributes, and displays images and data from all common modalities. | NovaPACS | NOVARAD CORPORATION | |
| 49 | B109NOVAPACS8650 | NovaPACS 8.6.5 | A picture archiving and communication system software that retrieves, archives, A picture archiving and communication system software that retrieves, archives, distributes, and displays images and data from all common modalities. | NovaPACS | NOVARAD CORPORATION | |
| 50 | B109NOVAPACS8640 | NovaPACS 8.6.4 | A picture archiving and communication system software that retrieves, archives, A picture archiving and communication system software that retrieves, archives, distributes, and displays images and data from all common modalities. | NovaPACS | NOVARAD CORPORATION |