FDA.report

HoloXR Health Connect

Primary DI
G721HXR0
Brand
HoloXR Health Connect
Company
Holoray Inc.
Model
1.0.0
Catalog number
HXR
Device description
The HoloXR Health Connect is an adjunctive tool to facilitate telecollaboration and consultation to gain the ability of leverage specialized clinicians for collaborative care from any location during surgical and outpatient procedures through real-time transmission of visual and auditory information.
Published
2025-02-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
LMDSystem, Digital Image Communications, Radiological

Product Code Classifications

CodeDeviceSpecialtyClass
LMDSystem, Digital Image Communications, RadiologicalRadiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
G721HXR0PrimaryHIBCC0

GMDN Terms

TermDefinition
Clinical training/education softwareA software program designed to train/educate a healthcare professional with respect to one or more clinical disease/disorder/condition. In addition to being an information platform it typically includes interactive features whereby, e.g., hypothetical patient data can be used to generate probabilities of presentation, diagnosis, and prognosis. It is not intended for real-case diagnostic or therapeutic purposes.

Sterilization Methods

Method

Regulatory Flags

DUNS number
240687301
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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