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FDA 510(k)

Viz RV/LV

K-Number: K221100 · 2022-08-29

ApplicantViz. Ai, Inc.
Decision Date2022-08-29
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Viz RV/LV is the device name listed in this FDA 510(k) record. The listed applicant is Viz. Ai, Inc.. It received FDA 510(k) clearance on 2022-08-29 under 510(k) number K221100. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Viz RV/LV?

Viz RV/LV is a medical device that received FDA 510(k) clearance on 2022-08-29. The listed applicant is Viz. Ai, Inc.. The 510(k) number is K221100.

When did Viz RV/LV receive FDA 510(k) clearance?

Viz RV/LV received FDA 510(k) clearance on 2022-08-29, under 510(k) number K221100.

Who is the listed applicant for Viz RV/LV?

The FDA 510(k) record lists Viz. Ai, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Viz RV/LV?

The FDA product code for Viz RV/LV is QIH.

Other records listing Viz. Ai, Inc. 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.

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Related Devices (Code: QIH)

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.

K253794Prostate CoreLucida Medical, Ltd.K252571mdprostateMediaire GmbHK253902RealGUIDE3DIEMME SRLK253835AffinityHermes Medical Solutions ABK260980cmAngio® V2.0Curemetrix, Inc.K261210Cleerly PlaqueCleerly, Inc.

Official Source

View on FDA Database →

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

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