OmnifyXR
Basic Information
- Brand Name
- OmnifyXR
- Primary DI
- 00850044606061
- Version / Model
- OXR-SYS
- Company Name
- Mediview Xr, Inc.
- Labeler DUNS
- 117407269
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-11-01
- Public Version
- 1
- Public Version Date
- 2023-11-09
- Public Version Status
- New
- Public Device Record Key
- 9b7437fc-cbfd-49ad-92b4-7afa2ecbbcd5
Device Description
The OmnifyXR is an adjunctive augmented reality display to interventional x-ray imaging systems. The system is comprised of a commercial off-the-shelf augmented reality display, wirelessly connected to a server that interfaces with the imaging system. It is intended to simultaneously display up to four video streams and a 3D surface model holographically using an augmented reality headset, and provides functions for display of the video streams, display of the 3D surface, and remote collaboration. The system allows for the management and selection of the video streams displayed and allows for adjusting position and orientation of the 3D surface model in the augmented reality display. The OmnifyXR system is capable of telemedicine collaboration, allowing verbal and visual collaboration with a remote healthcare professional by sharing the augmented reality display and audio. The device is intended to be used as a collaborative integration system. It is an open platform that combines input from key devices in the interventional suite and provides this data to the user in a simplified and efficient manner. It is intended for use by trained proceduralists in clinical intervention and for applications where imaging is currently used.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LMD | System, Digital Image Communications, Radiological | Radiology | 892.2020 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60723 | Medical image management system | A computerized image data management system designed to electronically receive, collect, store, and display a broad range of medical imaging/video data (non-dedicated), and to distribute the data within or between healthcare facilities to facilitate data analysis, organization, reporting, and sharing (e.g., teaching). The system consists of combined hardware (e.g., network switch, controller) and server/client software intended to relay image data from a broad range of imaging/audiovisual devices (e.g., endoscopic camera, ultrasound imaging system, radiography digital imaging system) to off-the-shelf devices [e.g., monitors, personal computers (PC’s)]. | No | Active |
| 60724 | Multidisciplinary medical image management software | A software application intended to be used to receive, collect, store, and display a broad range of medical imaging and/or video data, and to distribute the data within or between healthcare facilities to facilitate data analysis, organization, reporting, and sharing (e.g., teaching); it might be designed for holographic viewing of three-dimensional (3-D) images in conjunction with an appropriate headset or for real-time communication of diagnostic/surgical images, and might also enable the control of light settings of a device (e.g., microscope) for image acquisition. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850044606061 | GS1 |