| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 07290017025087 | 01 | MAU-EG20001 | LLZ | System, Image Processing, Radiological | 2 | Central Archive module | |
| 2 | 07290017025124 | 01 | ML-EG30001 | A native iOS and Android mobile application also compatible with iPad. It is use A native iOS and Android mobile application also compatible with iPad. It is used to:• Locate patients according to patient ID• Locate scheduled procedures by connecting to modality worklist• Capture videos, images and audio files to be included in the study case.• Add notes and tags to each file (asset).• Upload any file to the Orpheus System• Manually or automatically delete files from the file library | LLZ | System, Image Processing, Radiological | 2 | Orpheus CAST Mobile App Android OS |
| 3 | 07290017025094 | 01 | MAU-EG20004 | A Windows based desktop widget application that can be connected to the laptop’s A Windows based desktop widget application that can be connected to the laptop’s webcam, the Orpheus GATE or a USB connected camera.It is useful also to drag images from a USB connected camera/smartphone or from the PC/Laptop directory and upload to the Orpheus System.For example: discharge workflow in which clinicians record a video session with the patient explaining their care path and requirements after discharge. | LLZ | System, Image Processing, Radiological | 2 | Orpheus CAST App |
| 4 | 07290017025100 | 01 | MLL-EG30001 | A native iOS and Android mobile application also compatible with iPad. It is use A native iOS and Android mobile application also compatible with iPad. It is used to:• Locate patients according to patient ID• Locate scheduled procedures by connecting to modality worklist• Capture videos, images and audio files to be included in the study case.• Add notes and tags to each file (asset).• Upload any file to the Orpheus System• Manually or automatically delete files from the file library | LLZ | System, Image Processing, Radiological | 2 | Orpheus CAST Mobile App iOS + Android |
| 5 | 07290017025063 | 01 | MPU-EG00C01 | A "2 part" medical Foot Pedal connected to the Orpheus CAST to operate: start/s A "2 part" medical Foot Pedal connected to the Orpheus CAST to operate: start/stop, snapshot taking. | LLZ | System, Image Processing, Radiological | 2 | Foot Pedal |
| 6 | 07290017025049 | 01 | MCU-EG00408 | LLZ | System, Image Processing, Radiological | 2 | Orpheus CAST w/o Display OD Unit | |
| 7 | 07290017025025 | 01 | MCU-EG00402 | Application for sending a live video stream from the medical operating theater t Application for sending a live video stream from the medical operating theater to remote viewers.The class of HW devices with or without a touch panel display (TPD). It is used to connect to a video source and capture, archive and stream the video to the Orpheus System central server and over the multi-cast network to be viewed from the Orpheus Show application. | LLZ | System, Image Processing, Radiological | 2 | Orpheus CAST 24 inch HD Unit |
| 8 | 07290017025018 | 01 | MCU-EG00401 | Application for sending a live video stream from the medical operating theater t Application for sending a live video stream from the medical operating theater to remote viewers.The class of HW devices with or without a touch panel display (TPD). It is used to connect to a video source and capture, archive and stream the video to the Orpheus System central server and over the multi-cast network to be viewed from the Orpheus Show application. | LLZ | System, Image Processing, Radiological | 2 | Orpheus CAST 22 inch |
| 9 | 07290017025056 | 01 | MVU-EG00D01 | Multi viewer video switch | LLZ | System, Image Processing, Radiological | 2 | Orpheus Switch |
| 10 | 07290017025117 | 01 | MSU-EG30001 | 3rd party rack external server | LLZ | System, Image Processing, Radiological | 2 | Orpheus VOD CSS |
| 11 | 07290017025001 | 01 | MVD-0001 | The Orpheus System is a picture archival and communications systems (PACS) that The Orpheus System is a picture archival and communications systems (PACS) that is intended for image capturing, archiving, displaying and recording of audio/video sequences and patient data during a procedure. The system allows for capture and annotation of the surgical procedure for documentation purposes and for viewing at a later time either locally or on a secure distributed network. The captured audio/video sequences can be broadcasted in real time with video-conferencing capability during the broadcast. The Orpheus System is not intended to be used as a primary diagnostic system for mammography and any other radiology application. | LLZ | System, Image Processing, Radiological | 2 | Orpheus System |
| 12 | 07290017025032 | 01 | MCU-EG00407 | Application for sending a live video stream from the medical operating theater t Application for sending a live video stream from the medical operating theater to remote viewers.The class of HW devices with or without a touch panel display (TPD). It is used to connect to a video source and capture, archive and stream the video to the Orpheus System central server and over the multi-cast network to be viewed from the Orpheus Show application. | LLZ | System, Image Processing, Radiological | 2 | Orpheus CAST 15 inch |
| 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 |