| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 05415334027343 | MNA-440 DEC | MNA-440 DEC HDMI V2 | DXJ | DISPLAY, CATHODE-RAY TUBE, MEDICAL | 2 | Nexxis OR | |
| 2 | 05415334026612 | MDSC-8255 | K930793302B | MDSC-8255 LED NG | KQM | CAMERA, SURGICAL AND ACCESSORIES | 1 | Barco |
| 3 | 05415334000926 | MNA-120 | K9303151A | MNA-120 ENC ANA AUDIO TMS+CBL | DXJ | DISPLAY, CATHODE-RAY TUBE, MEDICAL | 2 | Nexxis |
| 4 | 05415334000667 | MNA-110 | K9303032A | MNA-110 ENC HDSDI | DXJ | DISPLAY, CATHODE-RAY TUBE, MEDICAL | 2 | Nexxis |
| 5 | 05415334033047 | Nexxis | K9605026 | NEXXIS SYSTEM X620 CM V3 | DXJ | DISPLAY, CATHODE-RAY TUBE, MEDICAL | 2 | Nexxis OR |
| 6 | 05415334002029 | MDNC-2123 | K9300331A | MDNC-2123 DE WP | PGY | Display, diagnostic radiology | 2 | Nio Color 2MP |
| 7 | 05415334002005 | MDNC-2221 | K9301654B | MDNC-2221 EM | LLZ | System, image processing, radiological | 2 | Nio Color 2MP |
| 8 | 05415334000384 | MDNC-2123 | K9300330A | MDNC-2123 DE WH | PGY | Display, diagnostic radiology | 2 | Nio Color 2MP |
| 9 | 05415334000377 | MDNC-2123 | K9300332A | MDNC-2123 EM BL | PGY | Display, diagnostic radiology | 2 | Nio Color 2MP |
| 10 | 05415334025974 | MDCC-6530 | K9301638A | MDCC-6530 NC | PGY | Display, diagnostic radiology | 2 | Coronis Fusion 6 MP |
| 11 | 05415334028401 | MDNG-6221 | K9300371B | MDNG-6221 NC EM | PGY | Display, Diagnostic Radiology | 2 | Nio 5.8MP Gray |
| 12 | 05415334002357 | MDNC-2123 | K9300330B | MDNC-2123 DE WH MKII | PGY | Display, diagnostic radiology | 2 | Nio Color 2MP |
| 13 | 05415334002326 | MDCC-6530 | K9301636A | MDCC-6530 | PGY | Display, diagnostic radiology | 2 | Coronis Fusion 6 MP |
| 14 | 05415334036895 | MDNG-6221 | K9300370B | MDNG-6221 SPEF | PGY | Display, Diagnostic Radiology | 2 | Nio 5.8MP Gray |
| 15 | 05415334036888 | MDNG-6221 | K9300372B | MDNG-6221 SNEF | PGY | Display, Diagnostic Radiology | 2 | Nio 5.8MP Gray |
| 16 | 05415334001541 | MDNG-5121 | K9300266C | MDNG-5121 CB (MA) | LLZ | System, image processing, radiological | 2 | MDNG-5121 CB (MA) |
| 17 | 05415334002623 | MDNC-2123 | K9300333B | MDNC-2123 NEU MKII | PGY | Display, diagnostic radiology | 2 | Nio Color 2MP |
| 18 | 05415334002616 | MDNC-2123 | K9300332B | MDNC-2123 EM BL MKII | PGY | Display, diagnostic radiology | 2 | Nio Color 2MP |
| 19 | 05415334002609 | MDNC-2123 | K9300331B | MDNC-2123 DE WP MKII | PGY | Display, diagnostic radiology | 2 | Nio Color 2MP |
| 20 | 05415334001992 | MDNC-3421 | K9300347A | MDNC-3421 EM | PGY | Display, diagnostic radiology | 2 | Nio Color 3MP |
| 21 | 05415334001916 | MDNC-3421 | K9300346A | MDNC-3421 DE | PGY | Display, diagnostic radiology | 2 | Nio Color 3MP |
| 22 | 05415334031326 | MDNC-3421II | K9300347B | MDNC-3421 EM MKII | PGY | Display, diagnostic radiology | 2 | Nio Color 3MP |
| 23 | 05415334030411 | MDNG-5221 | K9300350C | MDNG-5221 CB MKIII | LLZ | System, Image Processing, Radiological | 2 | Nio 5MP LED |
| 24 | 05415334030312 | MDNG-5221 | K9300351C | MDNG-5221 BB MKIII | LLZ | System, Image Processing, Radiological | 2 | Nio 5MP LED |
| 25 | 05415334002678 | MNA-440 | K9303310G | MNA-440 DEC HDMI | DXJ | DISPLAY, CATHODE-RAY TUBE, MEDICAL | 2 | Nexxis OR |
| 26 | 05415334002661 | MNA-440 | K9303310F | MNA-440 DEC HDMI | DXJ | DISPLAY, CATHODE-RAY TUBE, MEDICAL | 2 | Nexxis OR |
| 27 | 05415334002654 | MNA-440 | K9303310B | MNA-440 DEC HDMI | DXJ | DISPLAY, CATHODE-RAY TUBE, MEDICAL | 2 | Nexxis OR |
| 28 | 05415334002647 | MNA-440 ENC | K9303301 | MNA-440 ENC SDI | DXJ | DISPLAY, CATHODE-RAY TUBE, MEDICAL | 2 | Nexxis OR |
| 29 | 05415334002630 | MNA-420 ENC | K9303321 | MNA-420 ENC SDI | DXJ | DISPLAY, CATHODE-RAY TUBE, MEDICAL | 2 | Nexxis OR |
| 30 | 05415334027398 | MNA-420 DEC | k9303331B | MNA-420 DEC HDMI V2 | DXJ | DISPLAY, CATHODE-RAY TUBE, MEDICAL | 2 | Nexxis OR |
| 31 | 05415334027381 | MNA-420 DEC | k9303331X | MNA-420 DEC HDMI V2 | DXJ | DISPLAY, CATHODE-RAY TUBE, MEDICAL | 2 | Nexxis OR |
| 32 | 05415334027374 | MNA-440 DEC | k9303311x | MNA-440 DEC HDMI V2 | DXJ | DISPLAY, CATHODE-RAY TUBE, MEDICAL | 2 | Nexxis OR |
| 33 | 05415334027367 | MNA-440 DEC | k9303311B | MNA-440 DEC HDMI V2 | DXJ | DISPLAY, CATHODE-RAY TUBE, MEDICAL | 2 | Nexxis OR |
| 34 | 05415334027350 | MNA-440 DEC | k9303311F | MNA-440 DEC HDMI V2 | DXJ | DISPLAY, CATHODE-RAY TUBE, MEDICAL | 2 | Nexxis OR |
| 35 | 05415334027336 | MNA-420 DEC | k9303331F | MNA-420 DEC HDMI V2 | DXJ | DISPLAY, CATHODE-RAY TUBE, MEDICAL | 2 | Nexxis OR |
| 36 | 05415334027329 | MNA-420 DEC | K9303331G | MNA-420 DEC HDMI V2 UK | DXJ | DISPLAY, CATHODE-RAY TUBE, MEDICAL | 2 | Nexxis OR |
| 37 | 05415334027312 | MNA-420 DEC | k9303331I | MNA-420 DEC HDMI V2 | DXJ | DISPLAY, CATHODE-RAY TUBE, MEDICAL | 2 | Nexxis OR |
| 38 | 05415334026827 | MNA-420 DEC | K9303331 | MNA-420 DEC HDMI V2 | DXJ | DISPLAY, CATHODE-RAY TUBE, MEDICAL | 2 | Nexxis OR |
| 39 | 05415334026810 | MNA-440 DEC | MNA-440 DEC HDMI V2 | DXJ | DISPLAY, CATHODE-RAY TUBE, MEDICAL | 2 | Nexxis OR | |
| 40 | 05415334025233 | NMS 1.xx | Nexxis Management Suite | DXJ | DISPLAY, CATHODE-RAY TUBE, MEDICAL | 2 | Nexxis OR | |
| 41 | 05415334025011 | MNA-240 DEC | K9303275a | MNA-240 DEC V2 INC SFP+ | DXJ | DISPLAY, CATHODE-RAY TUBE, MEDICAL | 2 | Nexxis OR |
| 42 | 05415334002845 | MNA-440 ENC | K9303301X | MNA-440 ENC SDI | DXJ | DISPLAY, CATHODE-RAY TUBE, MEDICAL | 2 | Nexxis OR |
| 43 | 05415334002838 | MNA-440 ENC | K9303301I | MNA-440 ENC SDI | DXJ | DISPLAY, CATHODE-RAY TUBE, MEDICAL | 2 | Nexxis OR |
| 44 | 05415334002852 | Nexxis system | K9605022 | NEXXIS SYSTEM X670 CM US | DXJ | DISPLAY, CATHODE-RAY TUBE, MEDICAL | 2 | Nexxis OR |
| 45 | 05415334002821 | MNA-440 ENC | K9303301G | MNA-440 ENC SDI | DXJ | DISPLAY, CATHODE-RAY TUBE, MEDICAL | 2 | Nexxis OR |
| 46 | 05415334002814 | MNA-440 ENC | K9303301F | MNA-440 ENC SDI | DXJ | DISPLAY, CATHODE-RAY TUBE, MEDICAL | 2 | Nexxis OR |
| 47 | 05415334002807 | MNA-440 ENC | K9303301B | MNA-440 ENC SDI | DXJ | DISPLAY, CATHODE-RAY TUBE, MEDICAL | 2 | Nexxis OR |
| 48 | 05415334002791 | MNA-420 ENC | K9303321X | MNA-420 ENC SDI | DXJ | DISPLAY, CATHODE-RAY TUBE, MEDICAL | 2 | Nexxis OR |
| 49 | 05415334030220 | Nexxis | NEXXIS SYSTEM X620 CM V2 | DXJ | DISPLAY, CATHODE-RAY TUBE, MEDICAL | 2 | Nexxis OR | |
| 50 | 05415334030213 | Nexxis | NEXXIS SYSTEM X670 CM V2 | DXJ | DISPLAY, CATHODE-RAY TUBE, MEDICAL | 2 | Nexxis OR |
| 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 |