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VisAR

FDA UDI

Class II (US FDA UDI)

by Novarad Corporation

Identity

Trade Name
VisAR FDA UDI
Generic Name
Surgical planning/navigation-enhancement system FDA UDI
Device Name
VisAR is the combination of augmented reality glasses and Novarad’s medical imaging software to create stereoscopic three-dimensional images acquired from CT sources. FDA UDI
Model / Reference
VisAR 2.88 FDA UDI
Description
VisAR is the combination of augmented reality glasses and Novarad’s medical imaging software to create stereoscopic three-dimensional images acquired from CT sources. FDA UDI

Identifiers

Primary DI / UDI-DI
B109VISAR2880 FDA UDI
510(k) Number
K220146 FDA UDI
FDA Product Code
OLO FDA UDI
LLZ FDA UDI
GMDN Term
Surgical planning/navigation-enhancement system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.4560 FDA UDI
892.2050 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Surgical planning/navigation-enhancement system

VisAR by Novarad Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical planning/navigation-enhancement system.

Cleared under the same submission

K220146 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Novarad Corporation

Sources (1)

  • FDA UDI 27b22009-0f51-42f9-986f-82482e2d23bc 35 fields · synced Jun 6, 2026