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VisAR

by Novarad Corporation

510(k) K220146

VisAR is a medical device (FDA Class II; FDA product code OLO, Orthopedic Stereotaxic Instrument) made by Novarad Corporation, cleared under FDA 510(k) K220146 on 27 May 2022, active as of 22 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK220146 Date27 May 2022ClearedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
OLO
Device class
Class II
Regulation
21 CFR Part 882.4560
Advisory committee
Neurology
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Source: 510k-lineage (choiben314), CC BY 4.0

Devices cleared under K220146

5 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K220146
UDI-DISize and differences
VisAR 2.1.5
Novarad Corporation
VisAR 2.1.5B109VISAR2150 —On the market
VisAR 2.73
Novarad Corporation
VisAR 2.73B109VISAR2730 —On the market
VisAR 2.88
Novarad Corporation
VisAR 2.88B109VISAR2880 —On the market
VisAR 3.0.67
Novarad Corporation
VisAR 3.0.67B109VISAR30670 —On the market
VisAR 3.1.36
Novarad Corporation
VisAR 3.1.36B109VISAR31360 —On the market

Similar devices

Other devices filed under FDA product code OLO (Orthopedic Stereotaxic Instrument).

Other devices from Novarad Corporation

  • NovaPACS 9.1.5

    Class II

  • NovaPACS 9.1.6

    Class II

  • VisAR 3.0.67

    Class II

  • VisAR 3.1.36

    Class II

See all devices from Novarad Corporation →