| 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 | 03770016198004 | 1.X | QyScore | QYNAPSE | ||
| 2 | 03760297030209 | FXSPS001 | Planning software for total shoulder arthroplasty | FX Shoulder Positioning System | PIXEE MEDICAL | |
| 3 | 03760264690115 | 3.2.1 | M'Ath PACS | I M T | ||
| 4 | 03760264690061 | 3.2.1 SR | M'Ath | I M T | ||
| 5 | 03760263520024 | 6.0 | LMS-Liver is an image analysis software application for evaluating CT images cov LMS-Liver is an image analysis software application for evaluating CT images covering the liver area. It is designed to assist radiologists in the evaluation and documentation of lesions. It also provides tools for assessment of lesion evolution over time. LMS-Liver offers measurement tools and 3D registration techniques for characterization and follow-up of the lesions. It also offers reporting capabilities making it possible to generate standardized reports. | LMS-Liver | MEDIAN TECHNOLOGIES | |
| 6 | 03760263520017 | 6.0 | LMS-Lung/TRACK is intended to provide the radiologists and other clinicians qual LMS-Lung/TRACK is intended to provide the radiologists and other clinicians qualified to interpret CT images the ability to:- visualize chest CT datasets acquired in low or normal dose; - mark and automatically/manually measure characteristics (such as diameter, volume) of lung nodules selected by the user;- compare chest CT scans of the same patient over time for quantification of pulmonary lesion evolution (volume growth and doubling time estimation)- generate automatic reports. | LMS-Lung/TRACK | MEDIAN TECHNOLOGIES | |
| 7 | 03760262480015 | 3.1 | EndoSize | THERENVA | ||
| 8 | 03700757200858 | 1.x | spineEOS 1.x allows surgeons to perform preoperative surgical planning of spine spineEOS 1.x allows surgeons to perform preoperative surgical planning of spine surgeries in case of Adolescent Idiopathic Scoliosis (AIS) or deformative/degenerative spine. The software provides surgical tools for the correction of the curvature, for the placement of cages and for the achievement of osteotomies. | spineEOS | ONEFIT MEDICAL | |
| 9 | 03700757200834 | 3.x | hipEOS allows surgeons to perform pre-operative surgical planning for hip replac hipEOS allows surgeons to perform pre-operative surgical planning for hip replacement. The program features an extensive regularly updated library of digital 3D models of implants form leading implant manufacturers. It allows the overlay of the 3D/2D implant models on the radiological images and on the 3D reconstruction and permits the selection of appropriate size and position of implant. | hipEOS | ONEFIT MEDICAL | |
| 10 | 03700757200827 | 2.x | / | hipEOS allows surgeons to perform pre-operative surgical planning for hip replac hipEOS allows surgeons to perform pre-operative surgical planning for hip replacement. The program features an extensive regularly updated library of digital 3D models of implants form leading implant manufacturers. It allows the overlay of the 3D/2D implant models on the radiological images and on the 3D reconstruction and permits the selection of appropriate size and position of implant. | hipEOS | ONEFIT MEDICAL |
| 11 | 03700757200544 | 1.1 | spineEOS allows surgeons to perform preoperative surgical planning of spine surg spineEOS allows surgeons to perform preoperative surgical planning of spine surgeries in case of Adolescent Idiopathic Scoliosis (AIS) or deformative/degenerative spine. The software provides surgical tools for the correction of the curvature, for the placement of cages and for the achievement of osteotomies. | spineEOS | ONEFIT MEDICAL | |
| 12 | 03700757200520 | 2.5 | hipEOS allows surgeons to perform pre-operative surgical planning for hip replac hipEOS allows surgeons to perform pre-operative surgical planning for hip replacement. The program features an extensive regularly updated library of digital 3D models of implants form leading implant manufacturers. It allows the overlay of the 3D/2D implant models on the radiological images and on the 3D reconstruction and permits the selection of appropriate size and position of implant. | hipEOS | ONEFIT MEDICAL | |
| 13 | 03700757200506 | 1.0 | kneeEOS allows surgeons to perform preoperative surgical planning of total kneea kneeEOS allows surgeons to perform preoperative surgical planning of total kneearthroplasties. The software provides surgical tools to analyze preoperative data, to set the resection levels, to position and size the femoral and tibial components and to evaluate the final alignment of the leg. | kneeEOS | ONEFIT MEDICAL | |
| 14 | 03700719700471 | MYRIAN 2.9 | Myrian® is a medical software for processing, management, advanced visualization Myrian® is a medical software for processing, management, advanced visualization, and analysis of multimodality medical images. It includes DICOM communication, media interchange (printing, CD burning, storing) and reporting features. The software can be run from any standard client platform (such as PC) that might be purchased independently by the end user. Common users are trained medical professionals, including radiologists, surgeons, clinicians and technicians. This device is not indicated for mammography use. | MYRIAN | INTRASENSE | |
| 15 | 03700719700464 | MYRIAN 2.7.6 | Software medical device aimed at reviewing images produced by all standard medic Software medical device aimed at reviewing images produced by all standard medical Imaging devices. It includes DICOM communication, media interchange (printing, CD burning, storing) and reporting features. The software can be run from any standard client platform (such as PC) that might be purchased independently by the end user. Common users are trained medical professionals, including surgeons, radiologist clinicians and technicians. This device is not indicated for mammography use. Lossy compressed mammography images and digitized film screen images must not be used for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 mega pixel resolution and meets other technical specifications approved by the FDA. | MYRIAN | INTRASENSE | |
| 16 | 03700719700457 | MYRIAN 2.8 | Software medical device aimed at reviewing images produced by all standard medic Software medical device aimed at reviewing images produced by all standard medical Imaging devices. It includes DICOM communication, media interchange (printing, CD burning, storing) and reporting features. The software can be run from any standard client platform (such as PC) that might be purchased independently by the end user. Common users are trained medical professionals, including surgeons, radiologist clinicians and technicians. This device is not indicated for mammography use. Lossy compressed mammography images and digitized film screen images must not be used for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 mega pixel resolution and meets other technical specifications approved by the FDA. | MYRIAN | INTRASENSE | |
| 17 | 03700719700440 | MYRIAN 2.7 | Software medical device aimed at reviewing images produced by all standard medic Software medical device aimed at reviewing images produced by all standard medical Imaging devices. It includes DICOM communication, media interchange (printing, CD burning, storing) and reporting features. The software can be run from any standard client platform (such as PC) that might be purchased independently by the end user. Common users are trained medical professionals, including surgeons, radiologist clinicians and technicians. This device is not indicated for mammography use. Lossy compressed mammography images and digitized film screen images must not be used for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 mega pixel resolution and meets other technical specifications approved by the FDA. | MYRIAN | INTRASENSE | |
| 18 | 03700719700433 | MYRIAN 2.6 | Software medical device aimed at reviewing images produced by all standard medic Software medical device aimed at reviewing images produced by all standard medical Imaging devices. It includes DICOM communication, media interchange (printing, CD burning, storing) and reporting features. The software can be run from any standard client platform (such as PC) that might be purchased independently by the end user. Common users are trained medical professionals, including surgeons, radiologist clinicians and technicians. This device is not indicated for mammography use. Lossy compressed mammography images and digitized film screen images must not be used for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 mega pixel resolution and meets other technical specifications approved by the FDA. | MYRIAN | INTRASENSE | |
| 19 | 03700719700426 | MYRIAN 2.5 | Software medical device aimed at reviewing images produced by all standard medic Software medical device aimed at reviewing images produced by all standard medical Imaging devices. It includes DICOM communication, media interchange (printing, CD burning, storing) and reporting features. The software can be run from any standard client platform (such as PC) that might be purchased independently by the end user. Common users are trained medical professionals, including surgeons, radiologist clinicians and technicians. This device is not indicated for mammography use. Lossy compressed mammography images and digitized film screen images must not be used for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 mega pixel resolution and meets other technical specifications approved by the FDA. | MYRIAN | INTRASENSE | |
| 20 | 03700719700419 | MYRIAN 2.4 | Software medical device aimed at reviewing images produced by all standard medic Software medical device aimed at reviewing images produced by all standard medical Imaging devices. It includes DICOM communication, media interchange (printing, CD burning, storing) and reporting features. The software can be run from any standard client platform (such as PC) that might be purchased independently by the end user. Common users are trained medical professionals, including surgeons, radiologist clinicians and technicians. This device is not indicated for mammography use. Lossy compressed mammography images and digitized film screen images must not be used for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 mega pixel resolution and meets other technical specifications approved by the FDA. | MYRIAN | INTRASENSE | |
| 21 | 03700719700402 | MYRIAN 2.3 | Software medical device aimed at reviewing images produced by all standard medic Software medical device aimed at reviewing images produced by all standard medical Imaging devices. It includes DICOM communication, media interchange (printing, CD burning, storing) and reporting features. The software can be run from any standard client platform (such as PC) that might be purchased independently by the end user. Common users are trained medical professionals, including surgeons, radiologist clinicians and technicians. This device is not indicated for mammography use. Lossy compressed mammography images and digitized film screen images must not be used for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 mega pixel resolution and meets other technical specifications approved by the FDA. | MYRIAN | INTRASENSE | |
| 22 | 03700719700396 | MYRIAN 2.2 | Software medical device aimed at reviewing images produced by all standard medic Software medical device aimed at reviewing images produced by all standard medical Imaging devices. It includes DICOM communication, media interchange (printing, CD burning, storing) and reporting features. The software can be run from any standard client platform (such as PC) that might be purchased independently by the end user. Common users are trained medical professionals, including surgeons, radiologist clinicians and technicians. This device is not indicated for mammography use. Lossy compressed mammography images and digitized film screen images must not be used for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 mega pixel resolution and meets other technical specifications approved by the FDA. | MYRIAN | INTRASENSE | |
| 23 | 03700719700013 | MYRIAN 2.1 | Software medical device aimed at reviewing images produced by all standard medic Software medical device aimed at reviewing images produced by all standard medical Imaging devices. It includes DICOM communication, media interchange (printing, CD burning, storing) and reporting features. The software can be run from any standard client platform (such as PC) that might be purchased independently by the end user. Common users are trained medical professionals, including surgeons, radiologist clinicians and technicians. This device is not indicated for mammography use. Lossy compressed mammography images and digitized film screen images must not be used for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 mega pixel resolution and meets other technical specifications approved by the FDA. | MYRIAN | INTRASENSE | |
| 24 | 03665587000095 | 6.1 | MEDWS | MED.E.COM | ||
| 25 | 03665587000088 | 5.6 | MEDWS | MED.E.COM | ||
| 26 | 03665587000071 | 5.4 | MEDWS | MED.E.COM | ||
| 27 | 03665587000064 | 5.2 | MEDWS | MED.E.COM | ||
| 28 | 03665587000057 | 5.0 | MEDWS | MED.E.COM | ||
| 29 | 03665587000033 | 4.18 | MEDWS | MED.E.COM | ||
| 30 | 03665587000026 | 4.17 | MEDWS | MED.E.COM | ||
| 31 | 03665587000019 | 4.14 | MEDWS | MED.E.COM | ||
| 32 | 03665587000002 | 4.15 | MEDWS | MED.E.COM | ||
| 33 | 03665134000714 | KSOF-2602 | PROMAP – 3D PROSTATE SUITE | KOELIS | ||
| 34 | 03665134000684 | KURO-3000-3 | TRINITY | KOELIS | ||
| 35 | 03665134000578 | KURO-4000 | A system based on the PROMAP – 3D Prostate Suite range intended to define prosta A system based on the PROMAP – 3D Prostate Suite range intended to define prostate contour and targets the region of interest on a prostate gland image in anticipation of a fusion with a system compatible with a 3D echography image realized as part of a targeted prostate gland biopsy. | MR DRAW | KOELIS | |
| 36 | 03665134000035 | KURO3000-2 | A mobile workstation composed by a central unit with ultrasound beamformer, a A mobile workstation composed by a central unit with ultrasound beamformer, a tactile screen, a mouse, a touch pen and a footswitch. All these components are assembled on a mobile cart,Optionally a keyboard can be delivered and a trackball mouse can be delivered instead of the mouse. | TRINITY | KOELIS | |
| 37 | 03663999000054 | Software 1.8 | sterEOS workstation software | sterEOS® | EOS IMAGING | |
| 38 | 03663999000047 | Workstation 1.8 | sterEOS workstation | sterEOS® | EOS IMAGING | |
| 39 | 03663999000030 | Software 1.6 | sterEOS workstation software | sterEOS® | EOS IMAGING | |
| 40 | 03663999000023 | Workstation 1.6 | sterEOS workstation | sterEOS® | EOS IMAGING | |
| 41 | 03661489709067 | 0100011575 | e-Ortho Shoulder Software | FOURNITURES HOSPITALIERES INDUSTRIE | ||
| 42 | EKAV101244750 | 11 | 1.012.4475 | Software | DEXIS™ Software | DEXIS LLC |
| 43 | EKAV101135330 | 11 | 10124479 | Software | DEXIS™ Software | DEXIS LLC |
| 44 | EKAV101037680 | 3 | VIXWINPL | Imaging software | Gendex VixWin™ imaging software | GENDEX CORP. |
| 45 | EKAV101034120 | 9 | PLU238 | Enterprise | DEXIS™ Software | DEXIS LLC |
| 46 | EKAV101034110 | 9 | PLU349 | US & International | DEXIS™ Software | DEXIS LLC |
| 47 | EKAV101034090 | 9 | PLU235 | Animal | DEXIS™ Software | DEXIS LLC |
| 48 | EKAV101034080 | 9 | PLU236 | Forensic | DEXIS™ Software | DEXIS LLC |
| 49 | EKAV100879340 | 10 | 1.008.7934 | DEXIS 10 (DEXIS Imaging Suite) | DEXIS LLC | |
| 50 | 00889024486782 | 20-8017-038-00 | 20-8017-038-00 | X-PSI™ | ORTHOSOFT INC |