| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 00851455007959 | 90X0701 | CRYOCATH, 15" LIFEVUE, V3C-X15-R210, | KQM | Camera, Surgical And Accessories | 1 | LifeVue | |
| 2 | 00851455007393 | 90T2042 | ZEROWIRE ULTRA TX, DVI, SINGLE CHANNEL, WT-P11-11 | GCJ | Laparoscope, General & Plastic Surgery | 2 | ZEROWIRE | |
| 3 | 00818089021256 | 90X0531 | LIFEVUE 19", WALLMOUNT, W/TOUCH, CUSTOM KARL STORZ US, V3C-SX19-R130 | KQM | Camera, Surgical And Accessories | 1 | LifeVue | |
| 4 | 00818089021249 | 90X0530 | LIFEVUE 19", W/ DESKTOP STAND, W/TOUCH, CUSTOM KARL STORZ, V3C-SX19-R110 | KQM | Camera, Surgical And Accessories | 1 | LifeVue | |
| 5 | 00818089020433 | 90T0007 | ConductOR, ND-00B-M11/1 | LMD | System, Digital Image Communications, Radiological | 1 | ConductOR | |
| 6 | 00818089020365 | D065508 | ConductOR, ND-00B-M11/1 | LMD | System, Digital Image Communications, Radiological | 1 | ConductOR | |
| 7 | 00851455007515 | 90T2062 | ZEROWIRE ULTRA RX, DVI | GCJ | Laparoscope, General & Plastic Surgery | 2 | ZEROWIRE | |
| 8 | 00851455007768 | 90T2087 | ZEROWIRE G2 DUO, DVI, SDI, CUSTOM DEPUTY SYNTHES, NA | GCJ | Laparoscope, General & Plastic Surgery | 2 | ZEROWIRE | |
| 9 | 00851455007751 | 90T2089 | ZEROWIRE G2 TX UNIT, CUSTOM DEPUY SYNTHES | GCJ | Laparoscope, General & Plastic Surgery | 2 | ZEROWIRE | |
| 10 | 00851455007744 | 90T2088 | ZEROWIRE, G2 RX UNIT, CUSTOM DEPUY SYNTHES | GCJ | Laparoscope, General & Plastic Surgery | 2 | ZEROWIRE | |
| 11 | 00851455007713 | 90T2091 | ZEROWIRE G2 DUO, DVI, SDI, CUSTOM DEPUY SYNTHES, CHINA | GCJ | Laparoscope, General & Plastic Surgery | 2 | ZEROWIRE | |
| 12 | 00851455007676 | 90T2026 | CUSTOM OLYMPUS, ZEROWIRE RX, DVI, W/ACCESSORIES, WR-P13-11 | GCJ | Laparoscope, General & Plastic Surgery | 2 | ZEROWIRE | |
| 13 | 00851455007669 | 90T2058 | ZEROWIRE DUO, DVI, SDI, SINGLE CHANNEL | GCJ | Laparoscope, General & Plastic Surgery | 2 | ZEROWIRE | |
| 14 | 00851455007652 | 90T2025 | CUSTOM KARL STORZ GMBH, ZEROWIRE DUO, DVI | GCJ | Laparoscope, General & Plastic Surgery | 2 | ZEROWIRE | |
| 15 | 00851455007645 | 90R0110 | RADIANCE ULTR A32", PRIMARY ONLY, ZW RX, SC-WU32-G1518 | GCJ | Laparoscope, General & Plastic Surgery | 2 | ZEROWIRE | |
| 16 | 00851455007638 | 90R0109 | RADIANCE ULTRA 27" ZEROWIRE EMBEDDED | GCJ | Laparoscope, General & Plastic Surgery | 2 | ZEROWIRE | |
| 17 | 00851455007621 | 90R0115 | RADIANCE ULTRA 32" ZEROWIRE EMBEDDED | GCJ | Laparoscope, General & Plastic Surgery | 2 | ZEROWIRE | |
| 18 | 00851455007614 | 90T2072 | ZEROWIRE G2 TX, DVI, SDI, EMEA, WT-P42-13 | GCJ | Laparoscope, General & Plastic Surgery | 2 | ZEROWIRE | |
| 19 | 00851455007607 | 90T2071 | ZEROWIRE G2 RX, DVI, EMEA, WR-P42-11 | GCJ | Laparoscope, General & Plastic Surgery | 2 | ZEROWIRE | |
| 20 | 00851455007591 | 90T2070 | ZEROWIRE G2 DUO, DVI, SDI | GCJ | Laparoscope, General & Plastic Surgery | 2 | ZEROWIRE | |
| 21 | 00851455007584 | 90T2069 | CUSTOM PENTAX, ZEROWIRE ULTRA TX, DVI, SDI, WT-P13-13 | GCJ | Laparoscope, General & Plastic Surgery | 2 | ZEROWIRE | |
| 22 | 00851455007577 | 90T2068 | CUSTOM PENTAX, ZEROWIRE ULTRA RX, DVI, WR-P13-11 | GCJ | Laparoscope, General & Plastic Surgery | 2 | ZEROWIRE | |
| 23 | 00851455007560 | 90T2067 | CUSTOM PENTAX, ZEROWIRE ULTRA DUO, DVI, SDI | GCJ | Laparoscope, General & Plastic Surgery | 2 | ZEROWIRE | |
| 24 | 00851455007553 | 90T2066 | CUSTOM KARL STORZ, ZEROWIRE PLUS TX, DVI | GCJ | Laparoscope, General & Plastic Surgery | 2 | ZEROWIRE | |
| 25 | 00851455007546 | 90T2065 | CUSTOM KARL STORZ, ZEROWIRE PLUS RX, DVI | GCJ | Laparoscope, General & Plastic Surgery | 2 | ZEROWIRE | |
| 26 | 00851455007539 | 90T2064 | ZEROWIRE ULTRA TX, DVI, SDI | GCJ | Laparoscope, General & Plastic Surgery | 2 | ZEROWIRE | |
| 27 | 00851455007522 | 90T2063 | ZEROWIRE ULTRA TX, DVI | GCJ | Laparoscope, General & Plastic Surgery | 2 | ZEROWIRE | |
| 28 | 00851455007508 | 90T2061 | ZEROWIRE ULTRA TX, DVI, SDI, SINGLE CHANNEL, WT-P11-13 | GCJ | Laparoscope, General & Plastic Surgery | 2 | ZEROWIRE | |
| 29 | 00851455007492 | 90T2060 | ZEROWIRE ULTRA DUO, DVI, SDI, SINGLE CHANNEL | GCJ | Laparoscope, General & Plastic Surgery | 2 | ZEROWIRE | |
| 30 | 00851455007485 | 90T2059 | ZEROWIRE TX, DVI, SDI, W/ACCESSORIES, SINGLE CHANNEL, WT-P11-13 | GCJ | Laparoscope, General & Plastic Surgery | 2 | ZEROWIRE | |
| 31 | 00851455007478 | 90T2007 | ZEROWIRE DUO, DVI, SDI | GCJ | Laparoscope, General & Plastic Surgery | 2 | ZEROWIRE | |
| 32 | 00851455007461 | 90T2048U | UPGRADE KIT, KARL STORZ US, ZEROWIRE PLUS TX, DVI | GCJ | Laparoscope, General & Plastic Surgery | 2 | ZEROWIRE | |
| 33 | 00851455007454 | 90T2048 | CUSTOM KARL STORZ US, ZEROWIRE PLUS TX, DVI, WT-P13-11 | GCJ | Laparoscope, General & Plastic Surgery | 2 | ZEROWIRE | |
| 34 | 00851455007447 | 90T2047U | UPGRADE KIT, KARL STORZ US, ZEROWIRE PLUS RX, DVI | GCJ | Laparoscope, General & Plastic Surgery | 2 | ZEROWIRE | |
| 35 | 00851455007430 | 90T2047 | CUSTOM KARL STORZ US, ZEROWIRE PLUS RX, DVI, WR-P13-11 | GCJ | Laparoscope, General & Plastic Surgery | 2 | ZEROWIRE | |
| 36 | 00851455007386 | 90T2041 | ZEROWIRE ULTRA RX, DVI, SINGLE CHANNEL, WR-P11-11 | GCJ | Laparoscope, General & Plastic Surgery | 2 | ZEROWIRE | |
| 37 | 00851455007379 | 90T2040 | ZEROWIRE ULTRA DUO, DVI, SINGLE CHANNEL | GCJ | Laparoscope, General & Plastic Surgery | 2 | ZEROWIRE | |
| 38 | 00851455007362 | 90T2039U | UPGRADE KIT, ZEROWIRE ULTRA TX, DVI, SDI | GCJ | Laparoscope, General & Plastic Surgery | 2 | ZEROWIRE | |
| 39 | 00851455007355 | 90T2039 | ZEROWIRE ULTRA TX, DVI, SDI, WT-P13-13 | GCJ | Laparoscope, General & Plastic Surgery | 2 | ZEROWIRE | |
| 40 | 00851455007348 | 90T2038U | UPGRADE KIT, ZEROWIRE ULTRA DUO, DVI, SDI | GCJ | Laparoscope, General & Plastic Surgery | 2 | ZEROWIRE | |
| 41 | 00851455007331 | 90T2038 | ZEROWIRE ULTRA DUO, DVI, SDI | GCJ | Laparoscope, General & Plastic Surgery | 2 | ZEROWIRE | |
| 42 | 00851455007324 | 90T2037U | UPGRADE KIT, ZEROWIRE ULTRA TX, DVI | GCJ | Laparoscope, General & Plastic Surgery | 2 | ZEROWIRE | |
| 43 | 00851455007317 | 90T2037 | ZEROWIRE ULTRA TX, DVI, WT-P13-11 | GCJ | Laparoscope, General & Plastic Surgery | 2 | ZEROWIRE | |
| 44 | 00851455007300 | 90T2036U | UPGRADE KIT, ZEROWIRE ULTRA RX, DVI | GCJ | Laparoscope, General & Plastic Surgery | 2 | ZEROWIRE | |
| 45 | 00851455007294 | 90T2036 | ZEROWIRE ULTRA RX, DVI, WR-P13-11 | GCJ | Laparoscope, General & Plastic Surgery | 2 | ZEROWIRE | |
| 46 | 00851455007287 | 90T2035U | UPGRADE KIT, ZEROWIRE ULTRA DUO, DVI | GCJ | Laparoscope, General & Plastic Surgery | 2 | ZEROWIRE | |
| 47 | 00851455007270 | 90T2035 | ZEROWIRE ULTRA DUO, DVI | GCJ | Laparoscope, General & Plastic Surgery | 2 | ZEROWIRE | |
| 48 | 00851455007263 | 90T2013 | CUSTOM KARL STORZ, ZEROWIRE TX, DVI, SDI | GCJ | Laparoscope, General & Plastic Surgery | 2 | ZEROWIRE | |
| 49 | 00851455007232 | 90T2012 | CUSTOM KARL STORZ, ZEROWIRE DUO, DVI, SDI | GCJ | Laparoscope, General & Plastic Surgery | 2 | ZEROWIRE | |
| 50 | 00851455007225 | 90T2030 | CUSTOM KARL STORZ GMBH, ZEROWIRE TX, DVI, W/ACCESSORIES, SINGLE CHANNEL, WT-P11-11 | GCJ | Laparoscope, General & Plastic Surgery | 2 | ZEROWIRE |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | D962GGW00001 | Initial Release | Grin Website | GET-GRIN INC. | ||
| 2 | D962GGAW0002 | W Version | Grin App -W | GET-GRIN INC. | ||
| 3 | D962GGA00001 | Initial Release | Grin App | GET-GRIN INC. | ||
| 4 | 00818089021782 | 90T0021 | Custom Karl Storz, ScaleOR, DVI Input, W/O Fiber, No Accessory, ND-00B-014/0 | ScaleOR | NDS SURGICAL IMAGING LLC | |
| 5 | 00818089021775 | 90T0020 | ScaleOR, DVI Input, W/O Fiber, W/ DVI and 3G-SDI Cables, ND-00B-014/0 | ScaleOR | NDS SURGICAL IMAGING LLC | |
| 6 | 00818089021768 | 90T0019 | Custom Brainlab, ConductOR, ND-00B-M11/1 | ScaleOR | NDS SURGICAL IMAGING LLC | |
| 7 | 00818089021751 | 90T0018 | Custom Karl Storz, ScaleOR, DVI Input, W/O Fiber, ND-00B-014/0 | ScaleOR | NDS SURGICAL IMAGING LLC | |
| 8 | 00818089021744 | 90T0017 | ConductOR China, ND-00B-M11/1 | ScaleOR | NDS SURGICAL IMAGING LLC | |
| 9 | 00818089021737 | 90T0016 | ScaleOR, S-Video/Comp Input, W/ Single Fiber, ND-00B-015/0 | ScaleOR | NDS SURGICAL IMAGING LLC | |
| 10 | 00818089021720 | 90T0014 | ScaleOR, VGA Input, W/ Single Fiber, ND-00B-015/0 | ScaleOR | NDS SURGICAL IMAGING LLC | |
| 11 | 00818089021713 | 90T0012 | ScaleOR, SDI Input, W/ Single Fiber, ND-00B-015/0 | ScaleOR | NDS SURGICAL IMAGING LLC | |
| 12 | 00818089021706 | 90T0010 | ScaleOR, DVI Input, W/ Single Fiber, ND-00B-015/0 | ScaleOR | NDS SURGICAL IMAGING LLC | |
| 13 | 00818089020914 | 90V0003 | VIMA VIDEO MANAGER AND RECORDER ND-00D-T19/P | VIMA | NDS SURGICAL IMAGING LLC | |
| 14 | 00818089020907 | 90T0026 | ScaleOR, S-Video/Comp Input, HDBaseT, ND-00B-021/0 | ScaleOR | NDS SURGICAL IMAGING LLC | |
| 15 | 00818089020891 | 90T0025 | ScaleOR, VGA Input, HDBaseT, ND-00B-021/0 | ScaleOR | NDS SURGICAL IMAGING LLC | |
| 16 | 00818089020884 | 90T0024 | ScaleOR, SDI Input, HDBaseT, ND-00B-021/0 | ScaleOR | NDS SURGICAL IMAGING LLC | |
| 17 | 00818089020877 | 90T0023 | ScaleOR, DVI Input, HDBaseT, ND-00B-021/0 | ScaleOR | NDS SURGICAL IMAGING LLC | |
| 18 | 00818089020433 | 90T0007 | ConductOR, ND-00B-M11/1 | ConductOR | NDS SURGICAL IMAGING LLC | |
| 19 | 00818089020426 | 90R0036 | RADIANCE G2, 42" full MMI w/fiber | RADIANCE | NDS SURGICAL IMAGING LLC | |
| 20 | 00818089020365 | D065508 | ConductOR, ND-00B-M11/1 | ConductOR | NDS SURGICAL IMAGING LLC | |
| 21 | 00818089020143 | 90T0015 | ScaleOR, S-Video/Comp Input, W/O Fiber, ND-00B-014/0 | ScaleOR | NDS SURGICAL IMAGING LLC | |
| 22 | 00818089020136 | 90T0013 | ScaleOR, VGA Input, W/O Fiber, ND-00B-014/0 | ScaleOR | NDS SURGICAL IMAGING LLC | |
| 23 | 00818089020129 | 90T0011 | ScaleOR, SDI Input, W/O Fiber, ND-00B-014/0 | ScaleOR | NDS SURGICAL IMAGING LLC | |
| 24 | 00818089020112 | 90T0009 | ScaleOR, DVI Input, W/O Fiber, ND-00B-014/0 | ScaleOR | NDS SURGICAL IMAGING LLC | |
| 25 | 00810000890583 | IPS4000 | IPS4000 | Image Processing System | FSN | FORESEESON CUSTOM DISPLAYS, INC. |
| 26 | 00810000890576 | IPS100A | IPS100A | Image Processing System | FSN | FORESEESON CUSTOM DISPLAYS, INC. |
| 27 | 00810000890422 | WUH4000 (RX) | WUH4000 (RX) | Wireless Imaging System | FSN | FORESEESON CUSTOM DISPLAYS, INC. |
| 28 | 00810000890385 | WUH4000 (TX) | WUH4000 (TX) | Wireless Imaging System | FSN | FORESEESON CUSTOM DISPLAYS, INC. |
| 29 | 00810000890361 | IPS740DG, IPS740DS | IPS740DG, IPS740DS | Image Processing System | FSN | FORESEESON CUSTOM DISPLAYS, INC. |
| 30 | 00810000890279 | IPS500A | IPS500A | Image Processing System | FSN | FORESEESON CUSTOM DISPLAYS, INC. |
| 31 | 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 | |
| 32 | 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 | |
| 33 | 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 | |
| 34 | 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 | |
| 35 | 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 | |
| 36 | 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 | |
| 37 | 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 | |
| 38 | 00616258026428 | CAL-VIEWER | CAL-VIEWER | Calantic Viewer (88439783) | Calantic Viewer | BAYER MEDICAL CARE INC. |
| 39 | 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 | |
| 40 | B295VBB60 | 6 | Basic radiologist workstation | ViewBox Basic | RADIUS | |
| 41 | B295VBA10 | 1 | Advanced radiologist workstation | ViewBox Advanced | RADIUS | |
| 42 | B295PACSCORE60 | 6 | PACSCore back-end archive | PACSCore | RADIUS | |
| 43 | B295FULLPACS30 | 3 | ConnectWeb viewer front-end with PACSCore back-end archive | ConnectWeb with PACSCore | RADIUS | |
| 44 | B295DICOMFWD30 | 3 | Basic DICOM gateway | DicomForward | RADIUS | |
| 45 | 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. | |
| 46 | 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. | |
| 47 | AMBRMOBILEAPP0 | AMBRMOBILEAPP0 | Mobile Application version of Ambra Health. Not intended for diagnostic purposes. | Ambra Health Mobile Application | AMBRA HEALTH | |
| 48 | 60889978671366 | Vue RIS | 8671364 | RIS SOFTWARE < 25K EXAMS / YEAR | Vue RIS | CARESTREAM HEALTH, INC. |
| 49 | 60889976574645 | DRX - Ascend System | 6574644 | QG-TV-CM | DRX - Ascend System | CARESTREAM HEALTH, INC. |
| 50 | 60889976574638 | DRX - Ascend System | 6574636 | QG-TV10-C TECHVISION RS-590 WITH Q-VISIO | DRX - Ascend System | CARESTREAM HEALTH, INC. |