| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | INTUITION7 | AQNet Server | The AquariusNET Server, also known as iNtuition Server, receives, stores, transm The AquariusNET Server, also known as iNtuition Server, receives, stores, transmits and post-processes medical images from acquisition devices, in both DICOM and non-DICOM format. | LLZ | System, Image Processing, Radiological | 2 | iNtuition | |
| 2 | INTUITION6 | Aquarius Web | AquariusWeb Viewer (aka AqWeb or Web Viewer, marketing term) is a version of iNt AquariusWeb Viewer (aka AqWeb or Web Viewer, marketing term) is a version of iNtuitionEMV with a focus on 3D rendering, additionally providing workflow and scene support. | LLZ | System, Image Processing, Radiological | 2 | iNtuition | |
| 3 | INTUITION5 | iNtuition Mobile | iNtuition Mobile (aka AQMobile) refers to the client viewer designed for mobile devices. | LLZ | System, Image Processing, Radiological | 2 | iNtuition | |
| 4 | INTUITION3 | iNtuitionReview | iNtuitionReview (aka iReview or AquariusNET Viewer) is a 2D/basic 3D image clien iNtuitionReview (aka iReview or AquariusNET Viewer) is a 2D/basic 3D image client viewer that provides multi-monitor and multi-modality image review. | LLZ | System, Image Processing, Radiological | 2 | iNtuition | |
| 5 | INTUITION2 | ThinClient | ThinClient (aka AquariusNET Viewer or AquariusNET ThinClient) is a client viewer ThinClient (aka AquariusNET Viewer or AquariusNET ThinClient) is a client viewer with basic 2D/3D image viewing capabilities. | LLZ | System, Image Processing, Radiological | 2 | iNtuition | |
| 6 | INTUITION1 | Aquarius iNtuition Client | Aquarius iNtuition Client (aka AQi, Aquarius Workstation, or Aquarius Workstatio Aquarius iNtuition Client (aka AQi, Aquarius Workstation, or Aquarius Workstation iNtuition Client) is the most comprehensive client viewer with 2D/3D/4D image processing and visualization capabilities. | LLZ | System, Image Processing, Radiological | 2 | iNtuition | |
| 7 | AQAPS1 | AquariusAPS | The AquariusAPS server is a stand-alone medical device software which performs v The AquariusAPS server is a stand-alone medical device software which performs various kinds of data processing on incoming DICOM data sets, according to user pre-configured rules and schedules. | LLZ | System, Image Processing, Radiological | 2 | AquariusAPS | |
| 8 | B220843002A8430031 | Eureka AI Interoperability Platform | An application software program designed to function as a portal to allow softwa An application software program designed to function as a portal to allow software providers to make available radiological interpretive software [typically artificial intelligence (AI) based] for radiology professionals to access, use, evaluate, and compare. It is intended to facilitate distribution and hospital implementation of algorithms designed to assist image interpretation within a healthcare facility. | LMD | System, Digital Image Communications, Radiological | 1 | Eureka | |
| 9 | B2208430011 | Eureka AI Results Explorer | Eureka AI Results Explorer (aka Northstar AI Results Explorer and Northstar) is Eureka AI Results Explorer (aka Northstar AI Results Explorer and Northstar) is a zero-footprint, web-based software device indicated for use in clinical settings where medical images and image-derived metadata can be accessed or visualized to aid healthcare professionals in diagnosis and patient management decision making. Eureka AI Results Explorer’s web interfaces can obtain and consume both DICOM and non-DICOM image-derived metadata generated by Artificial Intelligence (AI) or computer vision algorithms. | LMD | System, Digital Image Communications, Radiological | 1 | Eureka | |
| 10 | AQAPS04 | AQAPS04 | AQAPS | AQAPS, also known as AquariusAPS Server, is a stand-alone medical device softwar AQAPS, also known as AquariusAPS Server, is a stand-alone medical device software which performs various kinds of data processing on incoming DICOM data sets, according to user pre-configured rules and schedules. | LLZ | System, Image Processing, Radiological | 2 | AQAPS |
| 11 | INTUITION9 | Intuition Thin Client | Intuition Thin Client (aka ThinClient and AquariusNET Viewer or AquariusNET Thin Intuition Thin Client (aka ThinClient and AquariusNET Viewer or AquariusNET ThinClient) is a client viewer with basic 2D/3D image viewing capabilities. | LLZ | System, Image Processing, Radiological | 2 | Intuition | |
| 12 | INTUITION8 | Intuition Client | Intuition Client (aka Aquarius iNtuition Client, AQi, Aquarius Workstation, or A Intuition Client (aka Aquarius iNtuition Client, AQi, Aquarius Workstation, or Aquarius Workstation iNtuition Client) is the most comprehensive client viewer with 2D/3D/4D image processing and visualization capabilities. | LLZ | System, Image Processing, Radiological | 2 | Intuition | |
| 13 | INTUITION12 | Intuition Server | The Intuition Server (aka AquariusNET Server and iNtuition Server) receives, sto The Intuition Server (aka AquariusNET Server and iNtuition Server) receives, stores, transmits and post-processes medical images from acquisition devices in DICOM and non-DICOM formats. | LLZ | System, Image Processing, Radiological | 2 | Intuition | |
| 14 | INTUITION11 | Intuition Web | Intuition Web (aka AquariusWeb Viewer and AqWeb or Web Viewer, marketing term) i Intuition Web (aka AquariusWeb Viewer and AqWeb or Web Viewer, marketing term) is a version of Intuition EMV (aka iNtuitionEMV) with a focus on 3D rendering, additionally providing workflow and scene support. | LLZ | System, Image Processing, Radiological | 2 | Intuition | |
| 15 | INTUITION10 | Intuition Mobile | Intuition Mobile ( aka iNtuition Mobile and AQMobile) refers to the client viewe Intuition Mobile ( aka iNtuition Mobile and AQMobile) refers to the client viewer designed for mobile devices. | LLZ | System, Image Processing, Radiological | 2 | Intuition | |
| 16 | INTUITION04 | Intuition04 | Intuition | Intuition (also referred to as Aquarius Intuition) is a medical device comprised Intuition (also referred to as Aquarius Intuition) is a medical device comprised of two stand-alone software components: a server software backend (Intuition Server) which performs complex image post processing and client viewer software (Intuition Client Viewers) that provides a user interface, enabling the user to view medical image data and associated derived metadata. The Intuition client viewer/server software enables 2D/3D/4D (3D with the dimension of time) image review, volume rendering, communications, storage, reporting, and image post processing. The Intuition software is used with off-the-shelf hardware, including a computer, monitor, keyboard and mouse.Intuition is comprised of six (6) separate client viewers: Intuition Client with Emergency Lung Docker, Intuition Thin Client, Intuition Review, Intuition EMV, Intuition Web Viewer, and Intuition Mobile. | LLZ | System, Image Processing, Radiological | 2 | Intuition |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 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 | |
| 2 | 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 | |
| 3 | 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 | |
| 4 | 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 | |
| 5 | 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 | |
| 6 | 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 | |
| 7 | 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 | |
| 8 | 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 | |
| 9 | 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 | |
| 10 | 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 | |
| 11 | 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 | |
| 12 | 04251332920023 | 1.12 | Visage Ease Pro | VISAGE IMAGING GMBH | ||
| 13 | 04251332920016 | 1.10 | Visage Ease Pro | VISAGE IMAGING GMBH | ||
| 14 | 04251332920009 | 1.8.2 | Visage Ease Pro | VISAGE IMAGING GMBH | ||
| 15 | 04251332910079 | 7.1.17 | Visage 7 | VISAGE IMAGING GMBH | ||
| 16 | 04251332910062 | 7.1.16 | Visage 7 | VISAGE IMAGING GMBH | ||
| 17 | 04251332910055 | 7.1.15 | Visage 7 | VISAGE IMAGING GMBH | ||
| 18 | 04251332910048 | 7.1.14 | Visage 7 | VISAGE IMAGING GMBH | ||
| 19 | 04251332910031 | 7.1.12 | Visage 7 | VISAGE IMAGING GMBH | ||
| 20 | 04251332910024 | 7.1.11 | Visage 7 | VISAGE IMAGING GMBH | ||
| 21 | 04251332910017 | 7.1.10 | Visage 7 | VISAGE IMAGING GMBH | ||
| 22 | 04251332910000 | 7.1.9 | Visage 7 | VISAGE IMAGING GMBH | ||
| 23 | 04250802900800 | 8.3 | DICOM picture archiving system | dicomPACS | OEHM UND REHBEIN GMBH | |
| 24 | 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 |
| 25 | 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 |
| 26 | 04056869955575 | 10400002 | MAMMOVISTA B.smart | SIEMENS HEALTHCARE GMBH | ||
| 27 | 04056869950181 | 11431561 | syngo.NM Organ Processing | SIEMENS MEDICAL SOLUTIONS USA, INC. | ||
| 28 | 04056869950174 | 11431560 | syngo.MI General | SIEMENS MEDICAL SOLUTIONS USA, INC. | ||
| 29 | 04056869950167 | 11431559 | syngo.MI Neurology | SIEMENS MEDICAL SOLUTIONS USA, INC. | ||
| 30 | 04056869950150 | 11431558 | syngo.MI Cardiology | SIEMENS MEDICAL SOLUTIONS USA, INC. | ||
| 31 | 04056869950143 | 11431557 | syngo.MM Oncology | SIEMENS MEDICAL SOLUTIONS USA, INC. | ||
| 32 | 04056869296210 | 11583169 | syngo.MR Applications | SIEMENS HEALTHCARE GMBH | ||
| 33 | 04056869285801 | 11582847 | syngo.via | SIEMENS HEALTHCARE GMBH | ||
| 34 | 04056869281230 | 10400002 | MAMMOVISTA B.smart | SIEMENS HEALTHCARE GMBH | ||
| 35 | 04056869274621 | 11545288 | AI-Rad Companion Brain MR About Box | AI-Rad Companion Brain MR | SIEMENS HEALTHCARE GMBH | |
| 36 | 04056869272320 | 11552102 | syngo Dynamics VA20I Medical Device Identifier | syngo Dynamics | SIEMENS HEALTHCARE GMBH | |
| 37 | 04056869272313 | 11552103 | syngo Dynamics VA20I Packaging Label | syngo Dynamics | SIEMENS HEALTHCARE GMBH | |
| 38 | 04056869270142 | 11461768 | syngo.via View&GO (Version VA20A) | syngo.via View&GO (Version VA20A) | SIEMENS HEALTHCARE GMBH | |
| 39 | 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 | |
| 40 | 04056869259901 | 11551864 | syngo Dynamics VA20H Package Label | syngo Dynamics | SIEMENS HEALTHCARE GMBH | |
| 41 | 04056869259802 | 11461857 | syngo.via VB50A Medical Device Identifier | syngo.via | SIEMENS HEALTHCARE GMBH | |
| 42 | 04056869257945 | 11294429 | AI-Rad Companion Brain MR About Box | AI-Rad Companion Brain MR | SIEMENS HEALTHCARE GMBH | |
| 43 | 04056869257921 | 11294424 | AI-Rad Companion Engine product label | AI-Rad Companion Engine | SIEMENS HEALTHCARE GMBH | |
| 44 | 04056869256399 | 11551643 | syngo Dynamics VA20H | syngo Dynamics | SIEMENS HEALTHCARE GMBH | |
| 45 | 04056869253244 | 10745960 | syngo Dynamics VA40 Software | syngo Dynamics | SIEMENS HEALTHCARE GMBH | |
| 46 | 04056869251202 | 11270035 | AI-Rad Companion (Engine) | SIEMENS HEALTHCARE GMBH | ||
| 47 | 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 | |
| 48 | 04056869247953 | 11368091 | syngo.via VB40A USB Media Virtual Container (Package) | syngo.via | SIEMENS HEALTHCARE GMBH | |
| 49 | 04056869247175 | 10745653 | syngo Dynamics VA20G Packaging Label | SIEMENS HEALTHCARE GMBH | ||
| 50 | 04056869247144 | 10745650 | syngo Dynamics VA20G | SIEMENS HEALTHCARE GMBH |