No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00884838074781 | 4.x | 837507 | IntelliSpace PACS is an image management system intended to be used by trained p IntelliSpace PACS is an image management system intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians. The system is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. The software performs digital image processing, measurement, communication and storage. Lossy compressed mammographic images and digitized screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA. | LLZ | System, image processing, radiological | 2 | IntelliSpace PACS |
2 | 00884838091740 | 4.x | 836344 | IntelliSpace Radiology Software (client) is a software package intended to be us IntelliSpace Radiology Software (client) is a software package intended to be used by trained professionals, including but not limited to Radiologists, physicians, administrators and medical technicians. The software is used with general purpose computing hardware for the presentation, processing, measurement and distribution of images and associated data throughout a clinical environment. IntelliSpace Radiology contains an Advanced Mammography module for functionality specific to Mammography. Lossy compressed mammographic images and digitized film/screen images must not be reviewed for primary image interpretations. Mammography images may only be interpreted using display monitors approved for digital mammography. | LLZ | System, image processing, radiological | 2 | IntelliSpace Radiology |
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 |