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 | 00850014885021 | 1.0 | jFit Software | JointVue jFit | JOINTVUE, LLC | |
2 | 00850014885007 | 1.0 | 3D Echo Software | JointVue 3D Echo | JOINTVUE, LLC | |
3 | 00850013331031 | HMD01 | HMD | CommandEP | SENTIAR, INC. | |
4 | 00850013331024 | ENC01 | Enclosure | CommandEP | SENTIAR, INC. | |
5 | 00850013331017 | DPC01 | Data Manager PC | CommandEP | SENTIAR, INC. | |
6 | 00850011790199 | 3.0DKR | MREPLUSV3 | Hepatogram Plus | RESOUNDANT, INC. | |
7 | 00850011790014 | MREplus 3.0.0WIN | MREplus | RESOUNDANT, INC. | ||
8 | 00850011790007 | MREplus 3.0.0DKR | MREplus | RESOUNDANT, INC. | ||
9 | 00850009343192 | 7.2 | A medical imaging software package that provides imaging solutions in the fields A medical imaging software package that provides imaging solutions in the fields of radiation oncology, radiology, nuclear medicine, neuroimaging, and cardiac imaging. | MIM | MIM SOFTWARE INC. | |
10 | 00850009343024 | 7.1 | A medical imaging software package that provides imaging solutions in the fields A medical imaging software package that provides imaging solutions in the fields of radiation oncology, radiology, nuclear medicine, neuroimaging, and cardiac imaging. | MIM | MIM SOFTWARE INC. | |
11 | 00850008977190 | DSC012-03 | PowerLook AMP with Density Assessment GE OUS | ICAD, INC. | ||
12 | 00850008977183 | DSC012-02 | PowerLook AMP with Density Assessment GE US | ICAD, INC. | ||
13 | 00850003095004 | 2.1.2.1 | Computer assisted reading tools designed to aid the radiologist in the detection Computer assisted reading tools designed to aid the radiologist in the detection of pulmonary nodules during review of CT examinations of the chest. | InferRead Lung CT.AI 2.1.2.1 | INFERVISION US INC | |
14 | 00850001088015 | 5 | suiteHEART Software is intended to assist trained clinical personnel in the qual suiteHEART Software is intended to assist trained clinical personnel in the qualification and quantification of cardiac function. The software provides the tools to adjust the parameters of the DICOM images and provides presentation states where the user can appreciate various MRI acquired images of the heart and vasculature over time. Additionally, the software provides tools for measuring linear distances, areas, and volumes that can be used to quantify cardiac function.Finally, the software provides the tools for volumetric flow measurements and the ability to calculate flow values. | suiteHEART | NEOSOFT LLC | |
15 | 00850001088008 | 4.0.7 | suiteHEART Software is intended to assist trained clinical personnel in the qual suiteHEART Software is intended to assist trained clinical personnel in the qualification and quantification of cardiac function. The software provides the tools to adjust the parameters of the DICOM images and provides presentation states where the user can appreciate various MRI acquired images of the heart and vasculature over time. Additionally, the software provides tools for measuring linear distances, areas, and volumes that can be used to quantify cardiac function. Finally, the software provides the tools for volumetric flow measurements and the ability to calculate flow values. | suiteHEART | NEOSOFT LLC | |
16 | 00842000101031 | 6.4 | Standalone Software Application | CADstream | MERGE HEALTHCARE SOLUTIONS INC. | |
17 | 00842000101024 | 9.0 | Correcting entry. | IBM iConnect Access | MERGE HEALTHCARE SOLUTIONS INC. | |
18 | 00842000101017 | 8.2 | IBM iConnect Access | MERGE HEALTHCARE SOLUTIONS INC. | ||
19 | 00842000100980 | 8.1 | IBM iConnect Access 8.1 | MERGE HEALTHCARE SOLUTIONS INC. | ||
20 | 00842000100935 | 8.2 | Merge PACS | MERGE HEALTHCARE SOLUTIONS INC. | ||
21 | 00842000100928 | 12.1 | Standalone software application | Merge Cardio | MERGE HEALTHCARE SOLUTIONS INC. | |
22 | 00842000100881 | 6.3 | Standalone Software Application | CADstream | MERGE HEALTHCARE SOLUTIONS INC. | |
23 | 00842000100867 | 4.3 | Standalone software application | eFilm Lite | MERGE HEALTHCARE SOLUTIONS INC. | |
24 | 00842000100850 | 4.3 | Standalone software application | eFilm Workstation | MERGE HEALTHCARE SOLUTIONS INC. | |
25 | 00842000100843 | 7.2 | IBM iConnect Access | MERGE HEALTHCARE SOLUTIONS INC. | ||
26 | 00842000100829 | 13.0 | Merge Unity PACS | MERGE HEALTHCARE SOLUTIONS INC. | ||
27 | 00842000100805 | 8.1 | Merge PACS | MERGE HEALTHCARE SOLUTIONS INC. | ||
28 | 00842000100782 | 7.1 | IBM iConnect Access | MERGE HEALTHCARE SOLUTIONS INC. | ||
29 | 00842000100775 | 8.0 | Merge OrthoPACS | MERGE HEALTHCARE SOLUTIONS INC. | ||
30 | 00842000100768 | 12.0.1 | Merge Cardio | MERGE HEALTHCARE SOLUTIONS INC. | ||
31 | 00842000100751 | 11.1 | Merge Cardio V11.1 | MERGE HEALTHCARE SOLUTIONS INC. | ||
32 | 00842000100744 | 12.0 | Merge Unity PACS | MERGE HEALTHCARE SOLUTIONS INC. | ||
33 | 00842000100737 | 8.0 | Merge PACS | MERGE HEALTHCARE SOLUTIONS INC. | ||
34 | 00842000100720 | 7.0 | IBM iConnect Access | MERGE HEALTHCARE SOLUTIONS INC. | ||
35 | 00842000100713 | 3.7.5 | Merge OrthoCase | MERGE HEALTHCARE SOLUTIONS INC. | ||
36 | 00842000100706 | 7.3 | Merge OrthoPACS | MERGE HEALTHCARE SOLUTIONS INC. | ||
37 | 00842000100690 | 7.3 | Merge PACS™ is a standards-based medical imaging diagnostic workstation that ser Merge PACS™ is a standards-based medical imaging diagnostic workstation that serves as an adjunct to assist the clinician to view, read, and report their findings. Merge PACS processes and displays medical images from DICOM-compliant modalities. The device is designed to enable efficient workflows by maintaining clinicians’ worklists and retrieving and managing studies for reading, reporting, communication, and storage.Merge PACS software runs on off-the-shelf computer hardware and can be configured to operate standalone or to integrate with vendor-neutral imaging archives (VNAs) such as iConnect Enterprise Archive (iCEA) for image storage, and with radiological and hospital information systems (RIS and HIS) and medical record systems (EMR, EHR, etc.). | Merge PACS | MERGE HEALTHCARE SOLUTIONS INC. | |
38 | 00842000100683 | 6.5 | Stand alone software application. | iConnect Access | MERGE HEALTHCARE SOLUTIONS INC. | |
39 | 00842000100676 | 7.2 | Merge OrthoPACS | MERGE HEALTHCARE SOLUTIONS INC. | ||
40 | 00842000100652 | 4.2.1 | eFilm Workstation | MERGE HEALTHCARE SOLUTIONS INC. | ||
41 | 00842000100645 | 6.4 | Software application that provides internet access to multi-modality softcopy me Software application that provides internet access to multi-modality softcopy medical images, reports and other patient related information for conducting diagnostic review, planning, and reporting through the interactive display and manipulation of medical data. | Merge iConnect Access | MERGE HEALTHCARE SOLUTIONS INC. | |
42 | 00842000100638 | 6.2 | Standalone Software Application | CADstream | MERGE HEALTHCARE SOLUTIONS INC. | |
43 | 00842000100614 | 8.32 | RadSuite | MERGE HEALTHCARE SOLUTIONS INC. | ||
44 | 00842000100607 | 7.1.0 | Standalone software application | Merge PACS | MERGE HEALTHCARE SOLUTIONS INC. | |
45 | 00842000100591 | 10.1 | Standalone software application | Merge Cardio | MERGE HEALTHCARE SOLUTIONS INC. | |
46 | 00842000100577 | 7.0.2 | Standalone software application | Merge OrthoPACS | MERGE HEALTHCARE SOLUTIONS INC. | |
47 | 00842000100560 | 7.0.2 | Standalone software application | Merge PACS | MERGE HEALTHCARE SOLUTIONS INC. | |
48 | 00842000100508 | 6.6.3.2 | Standalone software application | Merge PACS | MERGE HEALTHCARE SOLUTIONS INC. | |
49 | 00842000100478 | 7.1.2.1 | Merge PACS | MERGE HEALTHCARE SOLUTIONS INC. | ||
50 | 00842000100461 | 11.0 | Merge Unity Pacs | MERGE HEALTHCARE SOLUTIONS INC. |