OmnifyXR

GUDID 00850044606061

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.

Mediview Xr, Inc.

Medical image management system

• Primary Device ID: 00850044606061
• NIH Device Record Key: 9b7437fc-cbfd-49ad-92b4-7afa2ecbbcd5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OmnifyXR
• Version Model Number: OXR-SYS
• Company DUNS: 117407269
• Company Name: Mediview Xr, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850044606061 [Primary]

FDA Product Code

• LMD: System, Digital Image Communications, Radiological

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-11-09
• Device Publish Date: 2023-11-01

Devices Manufactured by Mediview Xr, Inc.

• 10860006066342 - EM Probe Bracket Kit, C1-6, Single: 2025-01-10 Single ultrasound probe bracket for use with GE C1-6-D transducers.
• 00860006066369 - XR90 System, LOGIQ: 2025-01-10
• 00860006066376 - XR90 System, LOGIQ, Single Headset: 2025-01-10
• 00860006066383 - XR90 System, LOGIQ, Upgrade Kit: 2025-01-10
• 00850044606061 - OmnifyXR: 2023-11-09The 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.
• 00850044606061 - OmnifyXR: 2023-11-09 The OmnifyXR is an adjunctive augmented reality display to interventional x-ray imaging systems. The system is comprised of a co
• 00850044606009 - Triangle Template Kit: 2023-11-01 MediView Triangle Template Kit for use with the XR90 system.
• 10850044606013 - Registration Marker Kit, Sterile, Single: 2023-10-31 MediView single sterile Registration Marker kit for use with XR90.
• 00850044606023 - EM Probe Bracket Kit, C1-5, Single: 2023-10-31 MediView XR90 single ultrasound probe bracket for use with GE C1-5-RS transducers.