VisAR 2.1.5

by Novarad Corporation

VisAR 2.1.5 is a Class II device made by Novarad Corporation, cleared under FDA 510(k) K220146 on 27 May 2022 and listed in FDA GUDID since 12 Feb 2024 (UDI-DI B109VISAR2150), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

FDA submission, from GUDID

Trust

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	NumberB109VISAR2150 UDI-DI	Date12 Feb 2024Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK220146	Date27 May 2022Decided	StatusActive

Official records

FDA 510(k) database 510(k) number K220146

Across registries

2 registries list this device

FDA 510(k) K220146 decided 27 May 2022 Active
FDA GUDID UDI-DI B109VISAR2150 listed 12 Feb 2024 Listed

Timeline

2 dated events

27 May 2022 Cleared FDA 510(k) K220146
12 Feb 2024 Listed FDA GUDID B109VISAR2150

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: VisAR
Generic name: Surgical planning/navigation-enhancement system
Model / reference: VisAR 2.1.5

Primary DI / UDI-DI: B109VISAR2150
510(k) Number: K220146
FDA product code: OLO
GMDN term: Surgical planning/navigation-enhancement system

Device class: Class II
Regulation number: 882.4560
GUDID distribution status: In Commercial Distribution

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Properties

Prescription use
Lot / batch number

Other properties (13, all answered No)