OmnifyXR

Primary DI
00850044606061
Brand
OmnifyXR
Company
Mediview Xr, Inc.
Model
OXR-SYS
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.
Published
2023-11-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
LMDSystem, Digital Image Communications, Radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LMDSystem, Digital Image Communications, RadiologicalRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850044606061PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850044606061008500446060618500446060610850044606061

GMDN Terms#

Term, Definition table
TermDefinition
Medical image management systemA 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)].

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
117407269
Device count
1
Premarket exempt
true
Serial number
true

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Primary DIBrandModelCatalogPublished
00850044606016Registration Marker Kit, Sterile, SingleSPEC-03032023-10-23
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00850044606047Kit, Aurora FG Mounting Brackets, RTXR90-BRK-FG-RT2023-10-23
00860006066345EM Probe Bracket Kit, C1-6, SingleSPEC-0551XR90-PBRK-C16-012025-01-02
10860006066342EM Probe Bracket Kit, C1-6, SingleSPEC-0551XR90-PBRK-C16-012025-01-02
00860006066369XR90 System, LOGIQXR90-SYS-LOGIQ2025-01-02
00860006066376XR90 System, LOGIQ, Single HeadsetXR90-LQ-HMD012025-01-02
00860006066383XR90 System, LOGIQ, Upgrade KitXR90-LQ-UPGRADE2025-01-02
00850044606023EM Probe Bracket Kit, C1-5, SingleSPEC-0310XR90-PBRK-C15-012023-10-23
00850044606054XR90XR90-SYS2023-10-23
00850044606009Triangle Template KitXR90-CT-KIT2023-10-24
10850044606013Registration Marker Kit, Sterile, SingleSPEC-03032023-10-23
00860006066307MediScout systemMS-100-10012021-04-20

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