No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 09353278000250 | P006105 | Kosmos Binaural Headset, ECG Patient Cable, Bridge Stand | DQD,DPS | Stethoscope, Electronic,Electrocardiograph | 2 | Kosmos Accessories - International | |
2 | 09353278000229 | P006200 | Radiological imaging system transport kit | IYO,IYN | System, Imaging, Pulsed Echo, Ultrasonic,System, Imaging, Pulsed Doppler, Ultrasonic | 2 | AI Station 2 | |
3 | 09353278000588 | P006576 | Ultrasound imaging system application software | IYO,IYN | System, Imaging, Pulsed Echo, Ultrasonic,System, Imaging, Pulsed Doppler, Ultrasonic | 2 | Kosmos OTS | |
4 | 09353278000519 | P006709 | Ultrasound imaging transducer, hand-held | ITX | Transducer, Ultrasonic, Diagnostic | 2 | Kosmos Lexsa | |
5 | 09353278000458 | R006030 | IYO,IYN,DQD,DPS | System, Imaging, Pulsed Echo, Ultrasonic,System, Imaging, Pulsed Doppler, Ultras System, Imaging, Pulsed Echo, Ultrasonic,System, Imaging, Pulsed Doppler, Ultrasonic,Stethoscope, Electronic,Electrocardiograph | 2 | Kosmos Bridge - Refurbished | ||
6 | 09369999064099 | P003994 | Extracorporeal ultrasound imaging system transducer, hand-held | ITX | Transducer, Ultrasonic, Diagnostic | 2 | Uscan Sector Probe (Japan) | |
7 | 09353278000694 | P007465 | Kosmos on Android software application for ultrasound imaging | IYO,IYN | System, Imaging, Pulsed Echo, Ultrasonic,System, Imaging, Pulsed Doppler, Ultrasonic | 2 | Kosmos OTS Android Linear Color | |
8 | 09353278000168 | R005195 | General ultrasound imaging system, battery-powered | IYO | System, Imaging, Pulsed Echo, Ultrasonic | 2 | EchoNous System - Refurbished | |
9 | 09353278000212 | P006115 | Electronic stethoscope | DQD | Stethoscope, Electronic | 2 | Kosmos Binaural Headset | |
10 | 09353278000571 | R006632 | Ultrasound imaging transducer, hand-held | ITX | Transducer, Ultrasonic, Diagnostic | 2 | Kosmos Torso-One - USB | |
11 | 09353278000540 | R006705 | General ultrasound imaging system, battery-powered | IYO | System, Imaging, Pulsed Echo, Ultrasonic | 2 | EchoNous System (Refurbished) | |
12 | 09353278000526 | R006210 | General ultrasound imaging system, battery-powered | IYO | System, Imaging, Pulsed Echo, Ultrasonic | 2 | EchoNous System (Refurbished) | |
13 | 09353278000502 | P006632 | ITX | Transducer, Ultrasonic, Diagnostic | 2 | Kosmos Torso-One - USB | ||
14 | 09353278000038 | P005195 | General ultrasound imaging system, battery-powered | IYO | System, Imaging, Pulsed Echo, Ultrasonic | 2 | Uscan System | |
15 | 09353278000403 | R003994 | Extracorporeal ultrasound imaging system transducer, hand-held | ITX | Transducer, Ultrasonic, Diagnostic | 2 | Uscan Sector Probe - Refurbished (Japan) | |
16 | 09353278000441 | R006025 | ITX,DQD | Transducer, Ultrasonic, Diagnostic,Stethoscope, Electronic | 2 | Kosmos Torso - Refurbished | ||
17 | 09353278000687 | P007213 | Kosmos on Android software application for ultrasound imaging | IYO,IYN | System, Imaging, Pulsed Echo, Ultrasonic,System, Imaging, Pulsed Doppler, Ultrasonic | 2 | Kosmos OTS Android Linear | |
18 | 09353278000007 | P003965 | General ultrasound imaging system, battery-powered | IYO | System, Imaging, Pulsed Echo, Ultrasonic | 2 | Uscan System | |
19 | 09353278000243 | P006186 | Electrocardiograph, professional, single-channelElectrocardiographic lead set, reusable | DPS | Electrocardiograph | 2 | Kosmos ECG Patient Cable - International | |
20 | 09353278000137 | P006025 | Extracorporeal ultrasound imaging system transducer, hand-heldElectronic stethoscope | ITX,DQD | Transducer, Ultrasonic, Diagnostic,Stethoscope, Electronic | 2 | Kosmos Torso | |
21 | 09353278000595 | P006966 | Ultrasound imaging system multi-transducer connection unit | IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 2 | Kosmos Hub | |
22 | 09353278000489 | R006115 | DQD | Stethoscope, Electronic | 2 | Binaural Headset - Refurbished | ||
23 | 09353278000465 | R006208 | Kosmos Binaural Headset, ECG Patient Cable, Bridge Stand | DQD,DPS | Stethoscope, Electronic,Electrocardiograph | 2 | Kosmos Accessories - US - Refurbished | |
24 | 09353278000618 | R006966 | Ultrasound imaging system multi-transducer connection unit | IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 2 | Kosmos Hub (Refurbished) | |
25 | 09353278000267 | P006208 | Kosmos Binaural Headset, ECG Patient Cable, Bridge Stand | DQD,DPS | Stethoscope, Electronic,Electrocardiograph | 2 | Kosmos Accessories - US | |
26 | 09353278000236 | P006210 | General ultrasound imaging system, battery-powered | IYO | System, Imaging, Pulsed Echo, Ultrasonic | 2 | EchoNous System | |
27 | 09353278000533 | P006705 | General ultrasound imaging system, battery-powered | IYO | System, Imaging, Pulsed Echo, Ultrasonic | 2 | EchoNous System | |
28 | 09353278000021 | P005194 | Extracorporeal ultrasound imaging system transducer, hand-held | ITX | Transducer, Ultrasonic, Diagnostic | 2 | Uscan Linear Probe | |
29 | 09353278000014 | R003951 | Extracorporeal ultrasound imaging system transducer, hand-held | ITX | Transducer, Ultrasonic, Diagnostic | 2 | Uscan Sector Probe - Refurbished | |
30 | 09353278000182 | R004104 | General ultrasound imaging system, battery-powered | IYO | System, Imaging, Pulsed Echo, Ultrasonic | 2 | Uscan System - Refurbished (Japan) | |
31 | 09353278000175 | R005600 | Extracorporeal ultrasound imaging system transducer, hand-held | ITX | Transducer, Ultrasonic, Diagnostic | 2 | EchoNous Bladder Probe - Refurbished | |
32 | 09353278000151 | R003965 | General ultrasound imaging system, battery-powered | IYO | System, Imaging, Pulsed Echo, Ultrasonic | 2 | Uscan System - Refurbished | |
33 | 09369999064082 | P003951 | Extracorporeal ultrasound imaging system transducer, hand-held | ITX | Transducer, Ultrasonic, Diagnostic | 2 | Uscan Sector Probe | |
34 | 09353278000410 | P006440 | ITX | Transducer, Ultrasonic, Diagnostic | 2 | Kosmos Torso-One | ||
35 | 09353278000625 | R006709 | Ultrasound imaging transducer, hand-held | ITX | Transducer, Ultrasonic, Diagnostic | 2 | Kosmos Lexsa (Refurbished) | |
36 | 09353278000601 | R005194 | Extracorporeal ultrasound imaging system transducer, hand-held | ITX | Transducer, Ultrasonic, Diagnostic | 2 | Uscan Linear Probe | |
37 | 09353278000120 | P006030 | Diagnostic ultrasound system with integrated electronic stethoscope and electroc Diagnostic ultrasound system with integrated electronic stethoscope and electrocardiographUltrasound/ electrocardiograph/ stethoscope unit | IYO,IYN,DQD,DPS | System, Imaging, Pulsed Echo, Ultrasonic,System, Imaging, Pulsed Doppler, Ultras System, Imaging, Pulsed Echo, Ultrasonic,System, Imaging, Pulsed Doppler, Ultrasonic,Stethoscope, Electronic,Electrocardiograph | 2 | Kosmos Bridge | |
38 | 09353278000113 | P005600 | Extracorporeal ultrasound imaging system transducer, hand-held | ITX | Transducer, Ultrasonic, Diagnostic | 2 | EchoNous Bladder Probe | |
39 | 09353278000083 | P004104 | General ultrasound imaging system, battery-powered | IYO | System, Imaging, Pulsed Echo, Ultrasonic | 2 | Uscan System (Japan) | |
40 | 09353278000076 | P005425 | Radiological imaging system transport kit | IYO | System, Imaging, Pulsed Echo, Ultrasonic | 2 | Uscan Mobile Stand | |
41 | 09353278000205 | P006024 | Radiological imaging system transport kit | IYO | System, Imaging, Pulsed Echo, Ultrasonic | 2 | Uscan Mobile Stand | |
42 | 09353278000144 | P005779 | Electrocardiograph, professional, single-channelElectrocardiographic lead set, reusable | DPS | Electrocardiograph | 2 | Kosmos ECG Patient Cable - US | |
43 | 09353278000069 | P005324 | An electronic unit that supports switching between multiple transducers, and cha An electronic unit that supports switching between multiple transducers, and charging of the display tablet and transducers. | IYO | System, Imaging, Pulsed Echo, Ultrasonic | 2 | Hub | |
44 | 09353278000434 | R006440 | ITX | Transducer, Ultrasonic, Diagnostic | 2 | Kosmos Torso-One - Refurbished | ||
45 | 09353278000199 | R005324 | An electronic unit that supports switching between multiple transducers, and cha An electronic unit that supports switching between multiple transducers, and charging of the display tablet and transducers. | IYO | System, Imaging, Pulsed Echo, Ultrasonic | 2 | Hub - Refurbished | |
46 | 09353278000052 | P005149 | Radiological imaging system transport kit | IYO | System, Imaging, Pulsed Echo, Ultrasonic | 2 | Mobile Stand |
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. |