FDA 510(k)

VisAR

K-Number: K220146 · 2022-05-27

Decision Date2022-05-27

Product CodeOLO

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

VisAR is the device name listed in this FDA 510(k) record. The listed applicant is Novarad Corporation. It received FDA 510(k) clearance on 2022-05-27 under 510(k) number K220146. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VisAR?

VisAR is a medical device that received FDA 510(k) clearance on 2022-05-27. The listed applicant is Novarad Corporation. The 510(k) number is K220146.

When did VisAR receive FDA 510(k) clearance?

VisAR received FDA 510(k) clearance on 2022-05-27, under 510(k) number K220146.

Who is the listed applicant for VisAR?

The FDA 510(k) record lists Novarad Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VisAR?

The FDA product code for VisAR is OLO.

Other records listing Novarad Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K172418OpenSight K171754NovaPACS K160371NovaPACS

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.