No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00860002545714 | 3.x | Koios Decision Support (DS) is a software application designed to assist trained Koios Decision Support (DS) is a software application designed to assist trained interpreting physicians in analyzing breast and thyroid ultrasound images. The software device is a web application that is deployed to a Microsoft IIS web server and accessed by a user through a compatible client. Once logged in and granted access to the Koios DS application, the user examines selected breast or thyroid ultrasound DICOM images. The user selects Regions of Interest (ROIs) of orthogonal views of a breast lesion or thyroid nodule for processing by Koios DS. The ROI(s) are transmitted electronically to the Koios DS server for image processing and the results are returned to the user for review. | POK,QIH | Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer,Automate Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer,Automated Radiological Image Processing Software | 2 | Koios DS |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 10885862578242 | 531-55-63 | Equinoxe | EXACTECH, INC. | ||
2 | 10885862591166 | 531-55-88 | Equinoxe | EXACTECH, INC. | ||
3 | 10885862586810 | 531-55-01 | Equinoxe | EXACTECH, INC. | ||
4 | 10885862583215 | 531-55-67 | Equinoxe | EXACTECH, INC. | ||
5 | 10885862583208 | 531-55-65 | Equinoxe | EXACTECH, INC. | ||
6 | 10885862583192 | 531-55-66 | Equinoxe | EXACTECH, INC. | ||
7 | 10885862583185 | 531-55-64 | Equinoxe | EXACTECH, INC. | ||
8 | 10885862583178 | 531-55-62 | Equinoxe | EXACTECH, INC. | ||
9 | 10885862578228 | 531-55-08 | Equinoxe | EXACTECH, INC. | ||
10 | 10885862578211 | 531-55-09 | Equinoxe | EXACTECH, INC. | ||
11 | 10885862578204 | 531-55-00 | Equinoxe | EXACTECH, INC. | ||
12 | 10885862578198 | 531-55-26 | Equinoxe | EXACTECH, INC. | ||
13 | 10885862542038 | 531-07-05 | 531-07-05 | SHOULDER GPS IMPACTOR HANDLE | GPS | EXACTECH, INC. |
14 | 10885862539229 | 531-29-15 | 531-29-15 | SHDLR GPS PEG DRL GD R16 | GPS | EXACTECH, INC. |
15 | 10885862539212 | 531-29-14 | 531-29-14 | SHDLR GPS PEG DRL GD L16 | GPS | EXACTECH, INC. |
16 | 10885862539205 | 531-27-15 | 531-27-15 | SHDLR GPS PEG DRL GD R 8 | GPS | EXACTECH, INC. |
17 | 10885862539199 | 531-27-14 | 531-27-14 | SHDLR GPS PEG DRL GD L 8 | GPS | EXACTECH, INC. |
18 | 10885862539182 | 531-27-05 | 531-27-05 | SHDLR GPS PEG DRL GD R | GPS | EXACTECH, INC. |
19 | 10885862539175 | 531-27-04 | 531-27-04 | SHDLR GPS PEG DRL GD L | GPS | EXACTECH, INC. |
20 | 10885862535641 | 1RL3-C01 | 1RL3-C01 | MEDTORQUE ZIMMER RATCHET AGILE HANDLE | NA | EXACTECH, INC. |
21 | 10885862527776 | 531-01-04 | 531-01-04 | OFF SHLDR GPS BLOCK R | GPS | EXACTECH, INC. |
22 | 10885862527769 | 531-01-03 | 531-01-03 | OFF SHLDR GPS BLOCK L | GPS | EXACTECH, INC. |
23 | 10885862518767 | L00041 | L00041 | SOFTWARE APPLICATION, TOTAL SHOULDER PLANNING | EXACTECHGPS | EXACTECH, INC. |
24 | 10885862319272 | 531-20-00 | 531-20-00 | SHLDR GPS RVRS DRILL KIT | GPS | EXACTECH, INC. |
25 | 10885862314338 | 531-27-63 | 531-27-63 | SHLDR GPS CAN CNTR DRILL | GPS | EXACTECH, INC. |
26 | 10885862314321 | 531-27-60 | 531-27-60 | SHOULDER GPS CNTR DRILL | GPS | EXACTECH, INC. |
27 | 10885862308238 | 531-07-50 | 531-07-50 | SHLDR GPS HUDSON ADAPTER | GPS | EXACTECH, INC. |
28 | 10885862308184 | 531-15-07 | 531-15-07 | SHOULDER GPS DRILL, 3.2mm | GPS | EXACTECH, INC. |
29 | 10885862308177 | 531-15-06 | 531-15-06 | Shoulder GPS 2.9mm Drill Bit | GPS | EXACTECH, INC. |
30 | 10885862308146 | 531-25-00 | 531-25-00 | SHLDR GPS MODULAR DRIVER | GPS | EXACTECH, INC. |
31 | 10884521783928 | CAVA | Emprint Ablation Visualization Application V2.0 | Emprint | COVIDIEN LP | |
32 | 10884521717411 | CAVA | Emprint Ablation Visualization Application V1.4 | Emprint | COVIDIEN LP | |
33 | 10884521214026 | CAMPA | Ablation Planning Application | Emprint | COVIDIEN LP | |
34 | 10884521214019 | CAMPV | VATS Planning Application | Emprint | COVIDIEN LP | |
35 | 10884521214002 | CAMPP | Procedure Planning Application | Emprint | COVIDIEN LP | |
36 | 10628634297015 | 0601 | CloudVue is a software application that allows for the display of medical image CloudVue is a software application that allows for the display of medical image data within a web browser without installing client software. Conceptually, the application comprises two components: the web viewer and the web server. The server is installed on any computer that meets the minimum system requirements and is configured to communicate with a DICOM archive. The server is capable of DICOM and DICOMweb communication, which allows the connected DICOM archive to exist on a physical server or in the cloud, giving institutions the flexibility to choose a system infrastructure that is best suited to their needs. CloudVue provides fast and secure access to full-fidelity CR, CT, DX, HC, IVUS, MR, NM, OP, OPT, OT, PT, SC, US, and XA images using Chrome, Safari, Firefox, or Edge web browsers. With interactive features, such as: multi-study viewing, multi-monitor support, customized screen and tool layouts, annotation saving and loading, measurement drawing and calibration, reference lines, key images, multi-planar reformatting (MPR), MIP, VR rendering, and image link sharing, CloudVue is a feature-rich solution that informs diagnostic decision-making by healthcare professionals. CloudVue also supports these same features across the following devices: Windows 10 and higher, macOS X and higher, iPad Pro 2nd generation and higher, and iPad Air 3 and higher. This level of portability allows healthcare professionals to access their medical image data anytime, anywhere. | CloudVue | INTERNATIONAL MEDICAL SOLUTIONS INC | |
37 | 10627843712777 | 2.x.y | densitas® densityai™ 2.6.4 | densitas® densityai™ | DENSITAS INCORPORATED | |
38 | 10627843712760 | 2.x.y | densitasdensity 2.4.1 | densitasdensity | DENSITAS INCORPORATED | |
39 | 10627843712753 | 2.1.0b | DM-Density | DENSITAS INCORPORATED | ||
40 | 10603295551287 | 451580053 | 451580053 | Cuptimize for Windows | CUPTIMIZE | DEPUY ORTHOPAEDICS, INC. |
41 | 10603295551270 | 451580054 | 451580054 | Cuptimize for Ios | CUPTIMIZE | DEPUY ORTHOPAEDICS, INC. |
42 | 10603295532040 | 451580052 | 451580052 | VELYS Hip Navigation for iOS | VELYS Hip Navigation | DEPUY ORTHOPAEDICS, INC. |
43 | 10603295522850 | 451580051 | 451580051 | VELYS Hip Navigation for Windows | VELYS Hip Navigation | DEPUY ORTHOPAEDICS, INC. |
44 | 09421904268319 | 4.0 | Volpara Density Map 4.0 | Volpara Density Map | VOLPARA HEALTH TECHNOLOGIES LIMITED | |
45 | 09421904268289 | 3.4.2 | Volpara Density Map 3.4.2 | Volpara Density Map | VOLPARA HEALTH TECHNOLOGIES LIMITED | |
46 | 09421904268258 | 3.4.2 | VolparaDensity 3.4.2 | VolparaDensity | VOLPARA HEALTH TECHNOLOGIES LIMITED | |
47 | 09421904268241 | 4.0 | VolparaDensity | VOLPARA HEALTH TECHNOLOGIES LIMITED | ||
48 | 09421904268166 | 3.4.1 | VolparaDensity 3.4.1 (Volpara Imaging Software 1.5.5.1) | VolparaDensity | VOLPARA HEALTH TECHNOLOGIES LIMITED | |
49 | 09421904268128 | 3.3 | Volpara Density Map 3.3 | Volpara Density Map | VOLPARA HEALTH TECHNOLOGIES LIMITED | |
50 | 09421904268098 | 3.3 | VolparaDensity 3.3 (Volpara Imaging Software 1.5.3 and 1.5.4) | VolparaDensity | VOLPARA HEALTH TECHNOLOGIES LIMITED |