| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 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 | LLZ | System, Image Processing, Radiological | 2 | Medis Suite XA 2D | |
| 2 | 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 | LLZ | System, Image Processing, Radiological | 2 | Medis Suite XA 2D | |
| 3 | 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. | LLZ | System, Image Processing, Radiological | 2 | Medis Suite MRCT | |
| 4 | 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. | LLZ | System, Image Processing, Radiological | 2 | Medis Suite MRCT | |
| 5 | 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. | LLZ | System, Image Processing, Radiological | 2 | Medis Suite MRCT | |
| 6 | 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. | LLZ | System, Image Processing, Radiological | 2 | Medis Suite MRCT | |
| 7 | 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. | LLZ | System, Image Processing, Radiological | 2 | Medis Suite MRCT | |
| 8 | 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. | LLZ | System, Image Processing, Radiological | 2 | Medis Suite MRCT | |
| 9 | 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. | LLZ | System, Image Processing, Radiological | 2 | Medis Suite MRCT | |
| 10 | 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. | LLZ | System, Image Processing, Radiological | 2 | QAngio XA | |
| 11 | 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. | LLZ | System, Image Processing, Radiological | 2 | QAngio XA 3D | |
| 12 | 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. | LLZ | System, Image Processing, Radiological | 2 | Medis Suite XA | |
| 13 | 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. | LLZ | System, Image Processing, Radiological | 2 | Medis Suite XA |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | G090AIM11 | 1 | AIM1 | AI Metrics is a thin client software application used with general purpose compu AI Metrics is a thin client software application used with general purpose computing hardware for the display and visualization of medical image data, supporting images and anatomical datasets, such as CT and MR. AI Metrics is designed as a workflow automation application with analytical tools to help the user assess, categorize and document the extent of a disease and/or tumor response to therapy in accordance with user selected standards (e.g. RECIST 1.1) and assess changes in imaging findings over multiple time-points. AI Metrics supports the interpretation and evaluation of examinations and follow up documentation of findings within healthcare institutions, for example, in Radiology, Oncology, and other Medical Imaging environments. AI Metrics functionality provides for communication, storage, processing, rendering, and display of DICOM compliant image data derived from various sources, navigation through images, selection of regions of interest, generation of information from those regions, evaluation in accordance with user selected standards, and generation of a structured report. The user controls these functions with a system of interactive menus and semi-automated or manual workflow automation tools, including: • Manual annotation tools for users to select regions of interest (ROIs), • Semi-automatic lesion segmentation suggestions for user-selected ROIs, • Automatic measurement and display of long and short axis of segmented lesions, • Automatic tabulation and summation of measurements,• Semi-automatic lesion labelling suggestions for anatomical location (organ, body region, and laterality), • Automatic calculation of quantitative and qualitative metrics using annotation data in accordance with the selected criteria, and • Automatic generation of a structured report that includes the annotation data and calculated quantitative and qualitative metrics presented in a graph, table, key images, and structured text report. | AI Metrics | AI METRICS, LLC |
| 2 | G01900 | 06 | ThinkingNet | THINKING SYSTEMS CORPORATION | ||
| 3 | G003DM01 | 1 | 3D printed patient specific replicas of patient anatomy | 3D Anatomic Model | RICOH USA, INC. | |
| 4 | EOLEOLEASPHEREV3P01 | 3.0 | Olea Sphere V3.0 is an image processing software package to be used by trained p Olea Sphere V3.0 is an image processing software package to be used by trained professionals including but not limited to physicians and medical technicians. The software runs on a standard "off-the-shelf" workstation and can be used to perform image viewing, processing, image collage and analysis of medical images. Data and images are acquired through DICOM compliant imaging devices and modalities. | OLEA SPHERE | OLEA MEDICAL USA | |
| 5 | EOLEOLEASPHEREV2P31 | 2.3 | Olea Sphere V2.3 is an image processing software package to be used by trained p Olea Sphere V2.3 is an image processing software package to be used by trained professionals including but not limited to physicians and medical technicians. The software runs on a standard "off-the-shelf" workstation and can be used to perform image viewing, processing, image collage and analysis of medical images. Data and images are acquired through DICOM compliant imaging devices and modalities. | OLEA SPHERE | OLEA MEDICAL USA | |
| 6 | EOLEFMRIV1P00 | V1.0 | Functional MR V1.0 is an optional image processing software application that is Functional MR V1.0 is an optional image processing software application that is intended for use on Olea Sphere® V3.0 software package. It is intended to be used by trained professionals including, but not limited to, physicians, MR technicians, radiographers.Functional MR V1.0 includes a software module that computes the activation map from a BOLD sequence and supports the visualization, analysis of activation maps. Functional MR V1.0 can also be used to provide reproducible measurements of derived maps. These measurements include thresholds modification and ROI analysis.Functional MR V1.0 may also be used as an image viewer of multi-modality digital images, including BOLD and DTI images. | FUNCTIONAL MR | OLEA MEDICAL USA | |
| 7 | EOLEBREASTSCAPEV1P00 | V1.0 | breastscape V1.0 is an optional image processing software application that is in breastscape V1.0 is an optional image processing software application that is intended for use on Olea Sphere V3.0 software package cleared under K152602. It is intended to be used by trained breast imaging physicians and trained MRI technologists.breastscape V1.0 includes 2 software modules :- BreastApp supports the visualization, analysis, and reporting of lesions measurements and analysis.- BreastLoc to assist users in planning MR guided breast interventional procedures.Data and images are acquired through DICOM compliant imaging devices and modalities. | BREASTSCAPE | OLEA MEDICAL USA | |
| 8 | 04260361440204 | TTA2.51 | TOMTEC-ARENA software is a clinical software package designed for review, quanti TOMTEC-ARENA software is a clinical software package designed for review, quantification and reporting of structures andfunction based on multi-dimensional digital medical data acquired with different modalities. TOMTEC-ARENA is not intended to beused for reading of mammography images. | TOMTEC-ARENA | TOMTEC IMAGING SYSTEMS GMBH | |
| 9 | 04260361440198 | TTA2.42 | TOMTEC-ARENA software is a clinical software package designed for review, quanti TOMTEC-ARENA software is a clinical software package designed for review, quantification and reporting of structures and function based on multi-dimensional digital medical data acquired with different modalities. TOMTEC-ARENA is not intended to be used for reading of mammography images. Indications for use of TOMTEC-ARENA software are quantification and reporting of cardiovascular, fetal, and abdominal structures and function of patients with suspected disease to support the physician in the diagnosis. | TOMTEC-ARENA | TOMTEC IMAGING SYSTEMS GMBH | |
| 10 | 04260361440181 | TTA2.50 | TOMTEC-ARENA software is a clinical software package designed for review, quanti TOMTEC-ARENA software is a clinical software package designed for review, quantification and reporting of structures and function based on multi-dimensional digital medical data acquired with different modalities.TOMTEC-ARENA is not intended to be used for reading of mammography images. | TOMTEC-ARENA | TOMTEC IMAGING SYSTEMS GMBH | |
| 11 | 04260361440174 | TTA2.41 | TOMTEC-ARENA software is a clinical software package designed for review, quanti TOMTEC-ARENA software is a clinical software package designed for review, quantification and reporting of structures and function based on multi-dimensional digital medical data acquired with different modalities. TOMTEC-ARENA is not intended to be used for reading of mammography images. Indications for use of TOMTEC-ARENA software are quantification and reporting of cardiovascular, fetal, and abdominal structures and function of patients with suspected disease to support the physician in the diagnosis. | TOMTEC-ARENA | TOMTEC IMAGING SYSTEMS GMBH | |
| 12 | 04260361440167 | TTA2.40 | TOMTEC-ARENA software is a clinical software package designed for review, quanti TOMTEC-ARENA software is a clinical software package designed for review, quantification and reporting of structures and function based on multi-dimensional digital medical data acquired with different modalities.TOMTEC-ARENA is not intended to be used for reading of mammography images.Indications for use of TOMTEC-ARENA software are quantification and reporting of cardiovascular, fetal, and abdominal structures and function of patients with suspected disease to support the physician in the diagnosis. | TOMTEC-ARENA | TOMTEC IMAGING SYSTEMS GMBH | |
| 13 | 04260361440150 | IA4 | The IMAGE-ARENA software platform is intended to import, export, store, retrieve The IMAGE-ARENA software platform is intended to import, export, store, retrieve and report digital studies. The IMAGE-ARENA software can import certain digital 2D or 3D image file formats of different modalities. IMAGE-ARENA offers a Generic Clinical Application Package interface in order to connect TOMTEC applications as well as commercially available analysis and quantification tools to the IMAGE-ARENA platform. It is intended as a general purpose digital medical image processing tool.IMAGE-ARENA is not intended to be used for reading of mammography images. | IMAGE-ARENA | TOMTEC IMAGING SYSTEMS GMBH | |
| 14 | 04260361440143 | TTA2 | TOMTEC-ARENA software is a clinical software package designed for review, quanti TOMTEC-ARENA software is a clinical software package designed for review, quantification and reporting of structures and function based on multi-dimensional digital medical data acquired with different modalities.TOMTEC-ARENA is not intended to be used for reading of mammography images. | TOMTEC-ARENA | TOMTEC IMAGING SYSTEMS GMBH | |
| 15 | 04251332920023 | 1.12 | Visage Ease Pro | VISAGE IMAGING GMBH | ||
| 16 | 04251332920016 | 1.10 | Visage Ease Pro | VISAGE IMAGING GMBH | ||
| 17 | 04251332920009 | 1.8.2 | Visage Ease Pro | VISAGE IMAGING GMBH | ||
| 18 | 04251332910079 | 7.1.17 | Visage 7 | VISAGE IMAGING GMBH | ||
| 19 | 04251332910062 | 7.1.16 | Visage 7 | VISAGE IMAGING GMBH | ||
| 20 | 04251332910055 | 7.1.15 | Visage 7 | VISAGE IMAGING GMBH | ||
| 21 | 04251332910048 | 7.1.14 | Visage 7 | VISAGE IMAGING GMBH | ||
| 22 | 04251332910031 | 7.1.12 | Visage 7 | VISAGE IMAGING GMBH | ||
| 23 | 04251332910024 | 7.1.11 | Visage 7 | VISAGE IMAGING GMBH | ||
| 24 | 04251332910017 | 7.1.10 | Visage 7 | VISAGE IMAGING GMBH | ||
| 25 | 04251332910000 | 7.1.9 | Visage 7 | VISAGE IMAGING GMBH | ||
| 26 | 04250802900800 | 8.3 | DICOM picture archiving system | dicomPACS | OEHM UND REHBEIN GMBH | |
| 27 | 04250802900411 | 5 | SW1000 | Professional acquisition software for the connection and control of a direct rad Professional acquisition software for the connection and control of a direct radiography detector (DR) with an up to date graphic user interface, intuitive operation via touch screen and an adaptable organ specific image processing. It also includes a diagnostic module standard and the multimedia radiographic positioning guide. | dicomPACS®DX-R | OEHM UND REHBEIN GMBH |
| 28 | 04250802900404 | 4.3 | SW1000 | Professional acquisition software for the connection and control of a direct rad Professional acquisition software for the connection and control of a direct radiography detector (DR) with an up to date graphic user interface, intuitive operation via touch screen and an adaptable organ specific image processing. It also includes a diagnostic module standard and the multimedia radiographic positioning guide. | dicomPACS®DX-R | OEHM UND REHBEIN GMBH |
| 29 | 04056869955575 | 10400002 | MAMMOVISTA B.smart | SIEMENS HEALTHCARE GMBH | ||
| 30 | 04056869950181 | 11431561 | syngo.NM Organ Processing | SIEMENS MEDICAL SOLUTIONS USA, INC. | ||
| 31 | 04056869950174 | 11431560 | syngo.MI General | SIEMENS MEDICAL SOLUTIONS USA, INC. | ||
| 32 | 04056869950167 | 11431559 | syngo.MI Neurology | SIEMENS MEDICAL SOLUTIONS USA, INC. | ||
| 33 | 04056869950150 | 11431558 | syngo.MI Cardiology | SIEMENS MEDICAL SOLUTIONS USA, INC. | ||
| 34 | 04056869950143 | 11431557 | syngo.MM Oncology | SIEMENS MEDICAL SOLUTIONS USA, INC. | ||
| 35 | 04056869296210 | 11583169 | syngo.MR Applications | SIEMENS HEALTHCARE GMBH | ||
| 36 | 04056869285801 | 11582847 | syngo.via | SIEMENS HEALTHCARE GMBH | ||
| 37 | 04056869281230 | 10400002 | MAMMOVISTA B.smart | SIEMENS HEALTHCARE GMBH | ||
| 38 | 04056869274621 | 11545288 | AI-Rad Companion Brain MR About Box | AI-Rad Companion Brain MR | SIEMENS HEALTHCARE GMBH | |
| 39 | 04056869272320 | 11552102 | syngo Dynamics VA20I Medical Device Identifier | syngo Dynamics | SIEMENS HEALTHCARE GMBH | |
| 40 | 04056869272313 | 11552103 | syngo Dynamics VA20I Packaging Label | syngo Dynamics | SIEMENS HEALTHCARE GMBH | |
| 41 | 04056869270142 | 11461768 | syngo.via View&GO (Version VA20A) | syngo.via View&GO (Version VA20A) | SIEMENS HEALTHCARE GMBH | |
| 42 | 04056869262567 | 11328180 | syngo Application Software VD3; covered by NFJ to K170747/K173611 syngo Applicat syngo Application Software VD3; covered by NFJ to K170747/K173611 syngo Application Software VD2 | syngo Application Software | SIEMENS HEALTHCARE GMBH | |
| 43 | 04056869259901 | 11551864 | syngo Dynamics VA20H Package Label | syngo Dynamics | SIEMENS HEALTHCARE GMBH | |
| 44 | 04056869259802 | 11461857 | syngo.via VB50A Medical Device Identifier | syngo.via | SIEMENS HEALTHCARE GMBH | |
| 45 | 04056869257945 | 11294429 | AI-Rad Companion Brain MR About Box | AI-Rad Companion Brain MR | SIEMENS HEALTHCARE GMBH | |
| 46 | 04056869257921 | 11294424 | AI-Rad Companion Engine product label | AI-Rad Companion Engine | SIEMENS HEALTHCARE GMBH | |
| 47 | 04056869256399 | 11551643 | syngo Dynamics VA20H | syngo Dynamics | SIEMENS HEALTHCARE GMBH | |
| 48 | 04056869253244 | 10745960 | syngo Dynamics VA40 Software | syngo Dynamics | SIEMENS HEALTHCARE GMBH | |
| 49 | 04056869251202 | 11270035 | AI-Rad Companion (Engine) | SIEMENS HEALTHCARE GMBH | ||
| 50 | 04056869248653 | 11327988 | syngo.Interventional VB40; Medical Device syngo.Interventional VB40 is covered b syngo.Interventional VB40; Medical Device syngo.Interventional VB40 is covered by NFJ to K190780 syngo Application Software VE20 | syngo.Interventional | SIEMENS HEALTHCARE GMBH |