| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 00850677007167 | 4.X | PACSgear Core Server | OUG | Medical Device Data System | 1 | PACSgear Core Server | |
| 2 | 00850677007341 | 3X | LLZ | System, Image Processing, Radiological | GearView Basic | |||
| 3 | 00850677007327 | 3X | LLZ | System, Image Processing, Radiological | 2 | GearView QC | ||
| 4 | 00850677007112 | 5 | PACS Scan Software CD | LLZ | System, Image Processing, Radiological | 2 | PACS Scan CD | |
| 5 | 00850677007211 | 3.X | Mod LInk | OUG | Medical Device Data System | 1 | PACSgear Mod Link | |
| 6 | 00850677007037 | 1 | Dicom Box Image Acquisition Unit | LMA | Digitizer, Image, Radiological | 2 | Dicom Box | |
| 7 | 00850677007006 | 5 | PACS Scan Software | LLZ | System, Image Processing, Radiological | 2 | PACS Scan | |
| 8 | 00850677007303 | 2.X | Encounter Manager | OUG | Medical Device Data System | 1 | Image Link Encounter Workflow | |
| 9 | 00850677007068 | MDR Video Cart | Cart for the MDR Video | LMA | Digitizer, Image, Radiological | 2 | MDR Video Cart | |
| 10 | 00850677007020 | 1 | MDR Video Image Acquisition | LMA | Digitizer, Image, Radiological | 2 | MDR Video | |
| 11 | 00850677007297 | 3.X | OUG | Medical Device Data System | 1 | Image Link | ||
| 12 | 00850677007266 | 3.X | OUG | Medical Device Data System | 1 | EHR-Gateway | ||
| 13 | 00850677007198 | 2.X | Image Link | OUG | Medical Device Data System | 1 | PACSgear Image Link | |
| 14 | 00850677007150 | 2.2.X | PSM2.2.2 | PACS Scan Mobile, Android | LMD | System, Digital Image Communications, Radiological | 1 | PACS Scan Mobile |
| 15 | 00850677007143 | 3.0 | PSM3.0 | The PACS Scan Mobile client is an application for mobile devices that can used t The PACS Scan Mobile client is an application for mobile devices that can used to easily capture images and videos and send them to patient studies on DICOM archives. The user queries and retrieves a patient study from a worklist, or creates a new patient record. The user may then take clinical photos and/or videos to send to the patient record. Photos may be manipulated (crop and rotate) and annotated prior to sending. Videos may not be altered prior to sending. Unwanted images may be deleted prior to sending. The user may also add a series description to the study. Typical users of the PACS Scan Mobile application are trained medical professionals, including but not limited to clinicians, technologists, assistants and lay persons. PSM is not intended for diagnostic use. | FXN,LMD | Tape, Camera, Surgical,System, Digital Image Communications, Radiological | 1 | PACS Scan Mobile |
| 16 | 00850677007235 | 2.X | EHR Gateway | OUG | Medical Device Data System | 1 | PACSgear EHR Gateway | |
| 17 | 00850677007228 | 3.X | Web Forms, Mod Link Web Forms | OUG | Medical Device Data System | 1 | PACSgear Web Forms | |
| 18 | 00850677007310 | 2.X | OUG | Medical Device Data System | 1 | EHR-Gateway Print | ||
| 19 | 00850677007242 | 1.X | Media Writer Web | LMD | System, Digital Image Communications, Radiological | 1 | PACSgear Media Writer Web | |
| 20 | 00850677007181 | 2.X | PACS Scan Web | LMD | System, Digital Image Communications, Radiological | 1 | PACSgear PACS Scan Web | |
| 21 | 00850677007419 | 5.2.X | CS.5.2 | PACSgear Enterprise Server is a program that processes DICOM and non-DICOM medic PACSgear Enterprise Server is a program that processes DICOM and non-DICOM medical data including patient demographics, images, videos and HL7 messages. It also handles user accounts, security, client configuration, and the folow of data between modalities and destination DICOM systems. PACSgear Enterprise exclusively supports PACSgear client products such as EHR Gateway, Image Link, MDR Video Touch and Web Forms. PACSgear Enterprise Server is not labeled for diagnostic use. | OUG | Medical Device Data System | 1 | PACSgear Enterprise Server |
| 22 | 00850677007396 | 5.1.X | PACSgear Enterprise Server is a program that processes DICOM and non-DICOM medic PACSgear Enterprise Server is a program that processes DICOM and non-DICOM medical data includingpatient demographics, images, videos, and HL7 messages. It also handles user accounts, security, clientconfiguration, and the flow of data between modalities and destination DICOM systems. PACSgear | OUG | Medical Device Data System | 1 | PACSgear Enterprise Server | |
| 23 | 00850677007389 | 1.X | Image Link Plus supports imaging workflows that do not follow the radiology work Image Link Plus supports imaging workflows that do not follow the radiology workflow by providing a pseudo order message to the modality that contains patient and visit information from the Electronic Medical Record (EMR). | OUG | Medical Device Data System | 1 | Image Link Plus | |
| 24 | 00850677007259 | 5.X | Core Server | OUG | Medical Device Data System | 1 | PACSgear Enterprise Server | |
| 25 | 00850677007204 | 1.X | Image Link Encounter Workflow | OUG | Medical Device Data System | 1 | PACSgear Image Link Encounter Workflow | |
| 26 | 00850677007136 | 5 | Media Writer CD | LMD | System, Digital Image Communications, Radiological | 1 | Media Writer CD | |
| 27 | 00850677007082 | 2 | Video Touch 4K | LMA | Digitizer, Image, Radiological | 2 | MDR Video Touch | |
| 28 | 00850677007075 | MDR Video Speech | Speech for the MDR Video | LMA | Digitizer, Image, Radiological | 2 | MDR Video Speech | |
| 29 | 00850677007051 | 2 | Gearview QC Software | LLZ | System, Image Processing, Radiological | 2 | Gearview QC | |
| 30 | 00850677007273 | 4.X | Web Forms | OUG | Medical Device Data System | 1 | ModLink Web Forms | |
| 31 | 00850677007129 | 5 | Media Writer Software | LMD | System, Digital Image Communications, Radiological | 1 | Media Writer | |
| 32 | 00850677007105 | 2 | GEAR VIEW QC CD | LLZ | System, Image Processing, Radiological | 2 | GEAR VIEW QC CD |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 00628105001830 | 8.3 | EasyViz is a software only medical device providing tools and features that may EasyViz is a software only medical device providing tools and features that may be used for general-purpose radiological viewing and reading (diagnosis) of image data fromvarious imaging modalities, clinical review and performs functions of digital image processing, measurement, communications and storage. EasyViz enables healthcareprofessionals and physicians to access patients’ medical images for making all patient management decisions. | EasyViz | CANON MEDICAL INFORMATICS A/S | |
| 2 | 00628105001823 | 8.2 | EasyViz is a software only medical device providing tools and features that may EasyViz is a software only medical device providing tools and features that may be used for general-purpose radiological viewing and reading (diagnosis) of image data fromvarious imaging modalities, clinical review and performs functions of digital image processing, measurement, communications and storage. EasyViz enables healthcareprofessionals and physicians to access patients’ medical images for making all patient management decisions. | EasyViz | CANON MEDICAL INFORMATICS A/S | |
| 3 | 00628105001816 | 8.1 | EasyViz is a software only medical device providing tools and features that may EasyViz is a software only medical device providing tools and features that may be used for general-purpose radiological viewing and reading (diagnosis) of image data fromvarious imaging modalities, clinical review and performs functions of digital image processing, measurement, communications and storage. EasyViz enables healthcareprofessionals and physicians to access patients’ medical images for making all patient management decisions. | EasyViz | CANON MEDICAL INFORMATICS A/S | |
| 4 | 00628105001809 | 8.0 | EasyViz is a software only medical device providing tools and features that may EasyViz is a software only medical device providing tools and features that may be used for general-purpose radiological viewing and reading (diagnosis) of image data fromvarious imaging modalities, clinical review and performs functions of digital image processing, measurement, communications and storage. EasyViz enables healthcareprofessionals and physicians to access patients’ medical images for making all patient management decisions. | EasyViz | CANON MEDICAL INFORMATICS A/S | |
| 5 | 00628105001779 | 7.7 | EasyViz is a diagnostic software image display workstation that has the ability EasyViz is a diagnostic software image display workstation that has the ability to work with EMR Systems. Powered by our unique adaptive streaming technology, it delivers simple and fast access to diagnostic quality imaging information when and where needed by Radiologists, Cardiologists, Clinicians and referring Physicians. | EasyViz | CANON MEDICAL INFORMATICS A/S | |
| 6 | 00628105001021 | 8.3.9 | EasyViz is a software only medical device providing tools and features that may EasyViz is a software only medical device providing tools and features that may be used for general-purpose radiological viewing and reading (diagnosis) of image data fromvarious imaging modalities, clinical review and performs functions of digital image processing, measurement, communications and storage. EasyViz enables healthcareprofessionals and physicians to access patients’ medical images for making all patient management decisions. | EasyViz | CANON MEDICAL INFORMATICS A/S | |
| 7 | 00628105001007 | 8.4 | Vitrea Read is a software only medical device providing tools and features that Vitrea Read is a software only medical device providing tools and features that may be used for general-purpose radiological viewing and reading (diagnosis) of image data from various imaging modalities, clinical review and performs functions of digital image processing, measurement, communications and storage. Vitrea Read enables healthcare professionals and physicians to access patients’ medical images for making all patient management decisions. | Vitrea Read | CANON MEDICAL INFORMATICS A/S | |
| 8 | 00616258026428 | CAL-VIEWER | CAL-VIEWER | Calantic Viewer (88439783) | Calantic Viewer | BAYER MEDICAL CARE INC. |
| 9 | B295VNA70 | 7 | PACSCore VNA archive with remote, remote backup, and optional local repositories PACSCore VNA archive with remote, remote backup, and optional local repositories, and ConnectWeb on remote archive | Vendor Neutral Archive with ConnectWeb | RADIUS | |
| 10 | B295VBB60 | 6 | Basic radiologist workstation | ViewBox Basic | RADIUS | |
| 11 | B295VBA10 | 1 | Advanced radiologist workstation | ViewBox Advanced | RADIUS | |
| 12 | B295PACSCORE60 | 6 | PACSCore back-end archive | PACSCore | RADIUS | |
| 13 | B295FULLPACS30 | 3 | ConnectWeb viewer front-end with PACSCore back-end archive | ConnectWeb with PACSCore | RADIUS | |
| 14 | B295DICOMFWD30 | 3 | Basic DICOM gateway | DicomForward | RADIUS | |
| 15 | 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. | Eureka | TERARECON INC. | |
| 16 | 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. | Eureka | TERARECON INC. | |
| 17 | AMBRMOBILEAPP0 | AMBRMOBILEAPP0 | Mobile Application version of Ambra Health. Not intended for diagnostic purposes. | Ambra Health Mobile Application | AMBRA HEALTH | |
| 18 | 60889978671366 | Vue RIS | 8671364 | RIS SOFTWARE < 25K EXAMS / YEAR | Vue RIS | CARESTREAM HEALTH, INC. |
| 19 | 60889976574645 | DRX - Ascend System | 6574644 | QG-TV-CM | DRX - Ascend System | CARESTREAM HEALTH, INC. |
| 20 | 60889976574638 | DRX - Ascend System | 6574636 | QG-TV10-C TECHVISION RS-590 WITH Q-VISIO | DRX - Ascend System | CARESTREAM HEALTH, INC. |
| 21 | 60889976573341 | QG-TV-IP-FM | 6573349 | QG-TV10-IPF-MAT TECHVISION QS-550 DRX AT | QG-TV-IP-FM | CARESTREAM HEALTH, INC. |
| 22 | 60889976573334 | QG-TV-IP-F | 6573331 | QG-TV10-IPF TECHVISION QS-550 WITH DRX | QG-TV-IP-F | CARESTREAM HEALTH, INC. |
| 23 | 60889976573327 | QG-TV-IP-CM | 6573323 | QG-TV10-IPC-MAT TECHVISION RS-590 DRX AT | QG-TV-IP-CM | CARESTREAM HEALTH, INC. |
| 24 | 60889976573310 | QG-TV-IP-C | 6573315 | QG-TV10-IPC TECHVISION RS-590 WITH DRX | QG-TV-IP-C | CARESTREAM HEALTH, INC. |
| 25 | 60889976571866 | DRX - Ascend System | 6571863 | TECHVISIN SYSTM,RS-590 WIT | DRX - Ascend System | CARESTREAM HEALTH, INC. |
| 26 | 60889974005226 | DRX - Ascend System | 1025907 | TECHVISION FOR CEILING SYSTEM | DRX - Ascend System | CARESTREAM HEALTH, INC. |
| 27 | 60889971065391 | QG-TV-IP-C | 1065390 | Techvision for Ceiling Systm | QG-TV-IP-C | CARESTREAM HEALTH, INC. |
| 28 | 15420045515369 | Cenova Server | Cenova | HOLOGIC, INC. | ||
| 29 | 15420045515345 | Cenova Server | Cenova | HOLOGIC, INC. | ||
| 30 | 15420045507449 | DICOM 6000 | DICOM 6000 | HOLOGIC, INC. | ||
| 31 | 15420045507395 | Cenova Server | Cenova | HOLOGIC, INC. | ||
| 32 | 15420045507388 | SVDX Manager | SecurView DX Manager | HOLOGIC, INC. | ||
| 33 | 15420045507371 | SVRT Manager | SecurViewRT Manager | HOLOGIC, INC. | ||
| 34 | 15420045507364 | SVRT | SecurViewRT Mammorgraphy Workstation | HOLOGIC, INC. | ||
| 35 | 10841736111731 | SDS | SVIS-SDS | SDS INTEGRATION W/22" TP | SkyVision | SKYTRON LLC |
| 36 | 10841736111724 | LINX 300 | SVIS-LINX | SkyVision LINX 300 Digital Integration system includes: Medical Grade Touch Pane SkyVision LINX 300 Digital Integration system includes: Medical Grade Touch Panel, Optical Router, IP addressable Control Switch and On-Board Uninterruptable Power Supply. | SkyVision | SKYTRON LLC |
| 37 | 09421904268074 | 1.3 | VolparaServer 1.3 | VolparaServer | VOLPARA HEALTH TECHNOLOGIES LIMITED | |
| 38 | 09353278000656 | P006598 | Kosmos UP | ECHONOUS, INC. | ||
| 39 | 08809278790345 | INFINITT RT Mobile | INFINITT RT Mobile | INFINITT HEALTHCARE CO.,LTD. | ||
| 40 | 07540293000033 | Archer 20 | Router for Tipso Airpad (TIPSO Router) | NZ Technologies Inc | NZ TECHNOLOGIES INC | |
| 41 | 07540293000026 | APADCHG-APL2 | Charging Dock (TIPSO AirPad® Charger) | NZ Technologies Inc | NZ TECHNOLOGIES INC | |
| 42 | 07540293000019 | UDNG-UD4 | TIPSO USB Dongle | NZ Technologies Inc | NZ TECHNOLOGIES INC | |
| 43 | 07540293000002 | APAD-APL2 | Tipso Airpad (A wireless controller) | NZ Technologies Inc | NZ TECHNOLOGIES INC | |
| 44 | 05415334039773 | MDRC-2222 | K9307942B | MDRC-2222 CK CT MK2 | Barco | BARCO NV |
| 45 | 05415334039766 | MDRC-2222 | K9307935B | MDRC-2222 CK C MK2 | Barco | BARCO NV |
| 46 | 05415334039759 | MDRC-2222 | K9307947B | MDRC-2222 WH MK2 | Barco | BARCO NV |
| 47 | 05415334039742 | MDRC-2222 | K9307945B | MDRC-2222 WP MK2 | Barco | BARCO NV |
| 48 | 05415334039728 | MDRC-2222 | K9307943B | MDRC-2222 TS MK2 | Barco | BARCO NV |
| 49 | 05415334038547 | MDRC-2222 | K9307944B | MDRC-2222 BL MK2 | Barco | BARCO NV |
| 50 | 05415334036260 | MDRC-2324 | 300006378031 | MDRC-2324 SPIB PHC | Barco | FIMI SRL |