VisAR

GUDID B109VISAR2150

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 Surgical planning/navigation-enhancement system Surgical planning/navigation-enhancement system Surgical planning/navigation-enhancement system Surgical planning/navigation-enhancement system Surgical planning/navigation-enhancement system Surgical planning/navigation-enhancement system Surgical planning/navigation-enhancement system Surgical planning/navigation-enhancement system Surgical planning/navigation-enhancement system Surgical planning/navigation-enhancement system Surgical planning/navigation-enhancement system Surgical planning/navigation-enhancement system Surgical planning/navigation-enhancement system Surgical planning/navigation-enhancement system

• Primary Device ID: B109VISAR2150
• NIH Device Record Key: 55b6969a-2501-4462-af18-45144c25856f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VisAR
• Version Model Number: VisAR 2.1.5
• 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
• 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	B109VISAR2150 [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: 2024-02-20
• Device Publish Date: 2024-02-12

Devices Manufactured by Novarad Corporation

• B109NOVAPACS81070 - NovaPACS: 2024-03-19 A picture archiving and communication system software that retrieves, archives, distributes, and displays images and data from a
• B109VISAR2150 - VisAR: 2024-02-20VisAR is the combination of augmented reality glasses and Novarad’s medical imaging software to create stereoscopic three-dimensional images acquired from CT sources.
• B109VISAR2150 - VisAR: 2024-02-20 VisAR is the combination of augmented reality glasses and Novarad’s medical imaging software to create stereoscopic three-dime
• B109NOVAPACS8780 - NovaPACS: 2023-10-18 A picture archiving and communication system software that retrieves, archives, distributes, and displays images and data from a
• B109OPENSIGHT187060 - OpenSight: 2023-10-18 OpenSight is the combination of augmented reality glasses and Novarad's medical imaging software to create three-dimensional hol
• B109NOVAPACS81030 - NovaPACS: 2023-07-10 A picture archiving and communication system software that retrieves, archives, distributes, and displays images and data from a
• B109NOVAPACS8930 - NovaPACS: 2022-10-03 A picture archiving and communication system software that retrieves, archives, distributes, and displays images and data from a
• B109NOVAPACS8920 - NovaPACS: 2022-07-19 A picture archiving and communication system software that retrieves, archives, distributes, and displays images and data from a
• B109NOVAPACS8910 - NovaPACS: 2022-04-26 A picture archiving and communication system software that retrieves, archives, distributes, and displays images and data from a