No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00763000138820 | 9732176 | KIT 9732176 TOUCH-N-GO | HAW | Neurological stereotaxic Instrument | 2 | N/A | |
2 | 00763000053994 | 9734404 | AWL 9734404 TIP | OLO | Orthopedic stereotaxic instrument | 2 | N/A | |
3 | 00763000053895 | 9734296 | TAP 9734296 3.75 | OLO | Orthopedic stereotaxic instrument | 2 | N/A | |
4 | 00763000053819 | 9734402 | PROBE 9734402 LUMBAR | OLO | Orthopedic stereotaxic instrument | 2 | N/A | |
5 | 00763000053802 | 9734403 | PROBE 9734403 THORACIC | OLO | Orthopedic stereotaxic instrument | 2 | N/A | |
6 | 00763000052966 | 9732565 | Dilator, 9732565, 100mm | HAW | Neurological stereotaxic Instrument | 2 | N/A | |
7 | 00643169843929 | 9735742 | SFW 9735742 STEALTH 3D ENT | PGW | Ear, Nose, and Throat Stereotaxic Instrument | 2 | NA | |
8 | 00885074314440 | 9731250 | PROBE 9731250 ENV CURVED SUCTION | HAW | Neurological stereotaxic Instrument | 2 | N/A | |
9 | 00885074549811 | 9732468 | INSERT 9732468 HIP NAVIGATION TRAY | HAW | Neurological stereotaxic Instrument | 2 | N/A | |
10 | 00885074549781 | 9732664 | TRAY, 9732664, HIP NAVIGATION INSTR | HAW | Neurological stereotaxic Instrument | 2 | N/A | |
11 | 00885074545066 | 9732389 | WRKSTN, 9732389, STEALTHSTATION INAV II | HAW | Neurological stereotaxic Instrument | 2 | N/A | |
12 | 00885074530369 | 9732626 | PINS 9732626 FIXATOR 3IN AND 5IN | HAW | Neurological stereotaxic Instrument | 2 | N/A | |
13 | 00885074517261 | 9732374XOM | INSTRUMENT 9732374XOM OSTIUM SEEKER ENV | HAW | Neurological stereotaxic Instrument | 2 | N/A | |
14 | 00885074515427 | 9732180 | CD, 9732180, LIBRARY - STEALTHLINK | HAW | Neurological stereotaxic Instrument | 2 | N/A | |
15 | 00885074515410 | 9732178 | KIT, 9732178, STEALTHLINK | HAW | Neurological stereotaxic Instrument | 2 | N/A | |
16 | 00885074511375 | 9732540 | SET 9732540 U ITHR INSTRUMENTS | HAW | Neurological stereotaxic Instrument | 2 | N/A | |
17 | 00885074511184 | 9732566 | ADAPTER 9732566 SHORT BED RAIL | HAW | Neurological stereotaxic Instrument | 2 | N/A | |
18 | 00885074510484 | 9732463 | CD 9732463 INSTALL U ITHR INAV | HAW | Neurological stereotaxic Instrument | 2 | N/A | |
19 | 00885074498140 | 9660246 | ADAPTER, 9660246, PATIENT TRACKER RADIOL | HAW | Neurological stereotaxic Instrument | 2 | N/A | |
20 | 00885074485058 | 9732576 | SFTWR 9732576 SECOND TOUCHSITE AUTOINS | HAW | Neurological stereotaxic Instrument | 2 | N/A | |
21 | 00885074447186 | 9732245 | FOOTSWITCH 9732245 WITH CABLE USB | HAW | Neurological stereotaxic Instrument | 2 | N/A | |
22 | 00885074445465 | 9732430 | SOFTWARE, 9732430, SPINE UNIFIED | OLO,MAX | Orthopedic stereotaxic instrument,Intervertebral fusion device with bone graft, lumbar | 2 | N/A | |
23 | 00885074435558 | 9731958 | INSTALL DVD 9731958 SPINE TOOLSA^ | OLO | Orthopedic stereotaxic instrument | 2 | N/A | |
24 | 00885074416922 | 9732296 | PROBE 9732296 LONG POINTER 2.5 BALL | HAW | Neurological stereotaxic Instrument | 2 | N/A | |
25 | 00885074403755 | 9732244 | SW 9732244 3D SPINE APPLICATION INAV | HAW | Neurological stereotaxic Instrument | 2 | N/A | |
26 | 00885074368856 | 9731883 | RACK 9731883 POLESTAR ASSY INT'L | HAW | Neurological stereotaxic Instrument | 2 | N/A | |
27 | 00885074368825 | 9731873 | CART 9731873 POLESTAR NAVIGATION ASSY | HAW | Neurological stereotaxic Instrument | 2 | N/A | |
28 | 00885074366722 | 9731838 | HARDWARE 9731838 POLESTAR INTEGRATION | HAW | Neurological stereotaxic Instrument | 2 | N/A | |
29 | 00885074366715 | 9731839 | VIEW STATION 9731839 ASSEMBLED | HAW | Neurological stereotaxic Instrument | 2 | N/A | |
30 | 00885074366661 | 9731844 | CART 9731844 POLESTAR VIEW STATION | HAW | Neurological stereotaxic Instrument | 2 | N/A | |
31 | 00885074361505 | 9731909 | ROD, 9731909, DETACHABLE PRF | LNH | System, nuclear magnetic resonance imaging | 2 | N/A | |
32 | 00885074348827 | 9732236 | SPRING PADDLE 9732236 PASSIVE | HAW | Neurological stereotaxic Instrument | 2 | N/A | |
33 | 00885074338255 | 9732221 | DG KIT 9732221 SHORT DRILL GUIDE | HAW | Neurological stereotaxic Instrument | 2 | N/A | |
34 | 00885074328225 | 9732176 | KIT, 9732176, TOUCH-N-GO | HAW | Neurological stereotaxic Instrument | 2 | N/A | |
35 | 00885074328195 | 9731965 | PROBE 9731965 BALL TIP ASSY - 4.3mm | HAW | Neurological stereotaxic Instrument | 2 | N/A | |
36 | 00885074281179 | 9732010 | WORKSTATION 9732010 DBS TDS | HAW | Neurological stereotaxic Instrument | 2 | N/A | |
37 | 00885074262086 | 9731968 | TRAY, 9731968, ORTHONAV STERILIZATION | HAW | Neurological stereotaxic Instrument | 2 | N/A | |
38 | 00885074240121 | 9731833 | DRIVER 9731833 1/4" BALL HEX | HAW | Neurological stereotaxic Instrument | 2 | N/A | |
39 | 00885074240114 | 9731450 | HOLDER 9731450 MOBILE LOCALIZER | HAW | Neurological stereotaxic Instrument | 2 | N/A | |
40 | 00885074240091 | 9731203 | FIELD GENERATOR 9731203 EM MOBILE | HAW | Neurological stereotaxic Instrument | 2 | N/A | |
41 | 00885074227337 | 9731808 | TRAY, 9731808 STERILIZATION | HAW | Neurological stereotaxic Instrument | 2 | N/A | |
42 | 00885074203027 | 9731567XOM | ARRAY 9731567XOM SURETRAK2 ORANGE | HAW | Neurological stereotaxic Instrument | 2 | N/A | |
43 | 00885074102641 | 9731110 | HANDLE 9731110 IMAGE GUIDED | HAW | Neurological stereotaxic Instrument | 2 | N/A | |
44 | 00885074140735 | 9731617 | MW 9731617 VM900 PTR ONLY INTF PLUS | HAW | Neurological stereotaxic Instrument | 2 | N/A | |
45 | 00885074129327 | 9731464 | BRACKET ADAPTER 9731464 MOLLER 20-1000 | HAW | Neurological stereotaxic Instrument | 2 | N/A | |
46 | 00885074098685 | 9731581 | ACC 9731581 INST TRAY ASSY, INAV | HAW | Neurological stereotaxic Instrument | 2 | N/A | |
47 | 00885074098586 | 9731238 | WORKSTATION 9731238 50901CONFIG EU | HAW | Neurological stereotaxic Instrument | 2 | NA | |
48 | 00885074098579 | 9731217 | WORKSTATION 9731217 50901 CONFIGURED US | HAW | Neurological stereotaxic Instrument | 2 | NA | |
49 | 00885074079448 | 9732110 | SFTWR 9732110 FRAMELINK WORKSTATION | HAW | Neurological stereotaxic Instrument | 2 | N/A | |
50 | 00885074079318 | 9731257 | WORKSTATION 9731257 DBS TDS UST | HAW | Neurological stereotaxic Instrument | 2 | N/A |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 17540266000029 | 4.6 | HeartPro is a web-accessible, self-contained image analysis software application HeartPro is a web-accessible, self-contained image analysis software application that analyzes DICOM-compliant cardiovascular images acquired from magnetic resonance (MR) scanners. HeartPro specifically analyzes the blood flow to the heart and its major vessels using multi-slice, multi-phase and velocity encoded MR images. | HeartPro | MEDVOXEL DIAGNOSTICS INC | |
2 | 17540266000012 | 4.5 | HeartPro is a web-accessible, self-contained image analysis software application HeartPro is a web-accessible, self-contained image analysis software application that analyzes DICOM-compliant cardiovascular images acquired from magnetic resonance (MR) scanners. HeartPro specifically analyzes the blood flow to the heart and its major vessels using multi-slice, multi-phase and velocity encoded MR images. | HeartPro | MEDVOXEL DIAGNOSTICS INC | |
3 | 17540262160055 | 1.0.1 | Change Healthcare Stratus Imaging PACS | CHANGE HEALTHCARE CANADA COMPANY | ||
4 | 17540262160048 | 1.1.0 | Change Healthcare Stratus Imaging PACS | CHANGE HEALTHCARE CANADA COMPANY | ||
5 | 17540262160031 | 1.0.0 | Change Healthcare Stratus Imaging PACS | CHANGE HEALTHCARE CANADA COMPANY | ||
6 | 17540262160024 | 0.7.0 | Change Healthcare Stratus Imaging PACS | CHANGE HEALTHCARE CANADA COMPANY | ||
7 | 17540262160017 | 0.6.0 | Change Healthcare Stratus Imaging PACS | CHANGE HEALTHCARE CANADA COMPANY | ||
8 | 17540262140026 | 25.0 | Nucleus.io | CHANGE HEALTHCARE CANADA COMPANY | ||
9 | 17540262140019 | 24 | Nucleus.io | CHANGE HEALTHCARE CANADA COMPANY | ||
10 | 17540262130126 | 1.0.11 | Change Healthcare Stratus Imaging Viewer | CHANGE HEALTHCARE CANADA COMPANY | ||
11 | 17540262130119 | 1.0.10 | Change Healthcare Stratus Imaging Viewer | CHANGE HEALTHCARE CANADA COMPANY | ||
12 | 17540262130102 | 1.0.9 | Change Healthcare Stratus Imaging Viewer | CHANGE HEALTHCARE CANADA COMPANY | ||
13 | 17540262130096 | 1.0.8 | Change Healthcare Stratus Imaging Viewer | CHANGE HEALTHCARE CANADA COMPANY | ||
14 | 17540262130089 | 1.0.7 | Change Healthcare Enterprise Imaging Network™ Viewer | CHANGE HEALTHCARE CANADA COMPANY | ||
15 | 17540262130072 | 1.0.6 | Change Healthcare Enterprise Imaging Network™ Viewer | CHANGE HEALTHCARE CANADA COMPANY | ||
16 | 17540262130065 | 1.0.5 | Change Healthcare Enterprise Imaging Network™ Viewer | CHANGE HEALTHCARE CANADA COMPANY | ||
17 | 17540262130058 | 1.0.4 | Change Healthcare Enterprise Imaging Network™ Viewer | CHANGE HEALTHCARE CANADA COMPANY | ||
18 | 17540262130041 | 1.0.3 | Change Healthcare Enterprise Imaging Network Viewer | CHANGE HEALTHCARE CANADA COMPANY | ||
19 | 17540262130034 | 1.0.2 | Change Healthcare Enterprise Imaging Network™ Viewer | CHANGE HEALTHCARE CANADA COMPANY | ||
20 | 17540262130027 | 1.0.1 | Change Healthcare Enterprise Imaging Network Viewer | CHANGE HEALTHCARE CANADA COMPANY | ||
21 | 17540262130010 | 1.0.0 | Change Healthcare Enterprise Imaging Network Viewer | CHANGE HEALTHCARE CANADA COMPANY | ||
22 | 17540262090116 | 15.0.1 | Change Healthcare Cardiology | CHANGE HEALTHCARE CANADA COMPANY | ||
23 | 17540262090109 | 15.0 | Change Healthcare Cardiology | CHANGE HEALTHCARE CANADA COMPANY | ||
24 | 17540262090055 | 14.3.2 | Change Healthcare Cardiology | CHANGE HEALTHCARE CANADA COMPANY | ||
25 | 17540262090048 | 14.3 | Change Healthcare Cardiology | CHANGE HEALTHCARE CANADA COMPANY | ||
26 | 17540262090031 | 14.2 | Change Healthcare Cardiology | CHANGE HEALTHCARE CANADA COMPANY | ||
27 | 17540262090024 | 14.1.1 | Change Healthcare Cardiology | CHANGE HEALTHCARE ISRAEL LTD | ||
28 | 17540262090017 | 14.1 | Change Healthcare Cardiology | CHANGE HEALTHCARE ISRAEL LTD | ||
29 | 17540262040029 | 2.2.0 | Conserus Enterprise Viewer | CHANGE HEALTHCARE CANADA COMPANY | ||
30 | 17540262040012 | 2.1 | Conserus Enterprise Viewer | CHANGE HEALTHCARE CANADA COMPANY | ||
31 | 17540262030037 | 14.1 | Change Healthcare Radiology Solutions | CHANGE HEALTHCARE CANADA COMPANY | ||
32 | 17540262030020 | 14.0 | Change Healthcare Radiology Solutions | CHANGE HEALTHCARE CANADA COMPANY | ||
33 | 17540262030013 | 12.4.1 | Change Healthcare Radiology Solutions | CHANGE HEALTHCARE CANADA COMPANY | ||
34 | 17540262020021 | 12.4 | McKesson Radiology | CHANGE HEALTHCARE CANADA COMPANY | ||
35 | 17540262020014 | 12.3 | McKesson Radiology | CHANGE HEALTHCARE CANADA COMPANY | ||
36 | 17540262010046 | 2.1.1 | Change Healthcare Enterprise Viewer | CHANGE HEALTHCARE CANADA COMPANY | ||
37 | 17540262010039 | 2.1 | Change Healthcare Enterprise Viewer | CHANGE HEALTHCARE CANADA COMPANY | ||
38 | 17540262010022 | 2.0 | Change Healthcare Enterprise Viewer | CHANGE HEALTHCARE CANADA COMPANY | ||
39 | 15420045512634 | Unifi Workspace V1.0 | Unifi Workspace | HOLOGIC, INC. | ||
40 | 15420045511859 | Unifi Workspace V1.0 | Unifi Workspace | HOLOGIC, INC. | ||
41 | 15420045510319 | 2.2 | Breast Density Assessment Software | Quantra | HOLOGIC, INC. | |
42 | 15420045504806 | 1.0 | DigitalNow HD | DigitalNow HD | HOLOGIC, INC. | |
43 | 15420045504790 | 2.1 | Breast Density Assessment | Quantra | HOLOGIC, INC. | |
44 | 15420045504691 | PRIMA | PRIMA | HOLOGIC, INC. | ||
45 | 15420045504684 | MultiView | MULTIVIEW | HOLOGIC, INC. | ||
46 | 15420045504523 | SecurView DX | SecurView Diagnostic Workstation | HOLOGIC, INC. | ||
47 | 14573443600029 | Ver.14.0.4.1 | ZedView | LEXI CO., LTD. | ||
48 | 14260495880331 | 3.3.0 | The product mint Lesion helps qualified radiologists with the image-based diagno The product mint Lesion helps qualified radiologists with the image-based diagnosis and treatment response assessment of oncological diseases. Fields of application are radiological diagnosis and follow-up examinations in oncology, as well as clinical or pharmaceutical drug trials across a defined group of patients. mint Lesion implements various radiological guidelines and response evaluation criteria, such as RECIST (Response Evaluation Criteria In Solid Tumors). This also includes the assessment of the stage of oncological disease (staging) and the objective response to therapy (e.g. timepoint response / overall response). The timepoint response is an empirical measure to evaluate therapy success according to the response criteria in use. It is mainly used to assess patient cohorts in the course of clinical trials of novel therapy agents. The timepoint response may differ from a radiological assessment of response to therapy and must not be used as a surrogate. mint Lesion allows for the documentation of size and assessment of changes in size of solid tumors described by the respective criteria that are monitored by means of radiological imaging (computed tomography (CT), magnetic resonance imaging (MRI), nuclear medicine (PET, NM), digital radiography (XR, CR)). mint Lesion follows the typical workflow of follow-up examinations, from assessment to reporting, and enables the integration of a clinical-radiological software environment (PACS, Picture Archiving and Communication System). Assessment results can be exported into different electronical formats and processed further by other applications. | mintLesion® | MINT MEDICAL GMBH | |
49 | M722Z19154V191210 | 1.0.2 | ClearRead CT Console | ClearRead CT Console | RIVERAIN TECHNOLOGIES, INC. | |
50 | M722Z19122V191210 | 1.0.1.32 | ClearRead CT Console | ClearRead CT Console | RIVERAIN TECHNOLOGIES, INC. |