VisAR

GUDID B109VISAR30670

VisAR is the combination of augmented reality glasses and Novarad's medical imaging software to create stereoscopic three-dimensional images acquired from CT sources.

Novarad Corporation

Surgical planning/navigation-enhancement system

• Primary Device ID: B109VISAR30670
• NIH Device Record Key: 6a36c4e1-a61e-4539-b9ba-bd56529b2de6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VisAR
• Version Model Number: VisAR 3.0.67
• Company DUNS: 071991843
• Company Name: Novarad Corporation
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: true
• Serial Number: false
• 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

Customer Support Contacts

• Phone: 18776682723
• Email: info@novarad.net
• Phone: 18776682723
• Email: info@novarad.net
• Phone: 18776682723
• Email: info@novarad.net
• Phone: 18776682723
• Email: info@novarad.net
• Phone: 18776682723
• Email: info@novarad.net
• Phone: 18776682723
• Email: info@novarad.net
• Phone: 18776682723
• Email: info@novarad.net
• Phone: 18776682723
• Email: info@novarad.net
• Phone: 18776682723
• Email: info@novarad.net
• Phone: 18776682723
• Email: info@novarad.net
• Phone: 18776682723
• Email: info@novarad.net

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B109VISAR30670 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220146

FDA Product Code

• OLO: Orthopedic Stereotaxic Instrument

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: 2025-12-19
• Device Publish Date: 2025-12-11

On-Brand Devices [VisAR]

• B109VISAR2150: VisAR is the combination of augmented reality glasses and Novarad’s medical imaging software t
• B109VISAR30670: VisAR is the combination of augmented reality glasses and Novarad's medical imaging software to