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FDA 510(k)

Viz ANEURYSM, Viz ANX

K-Number: K213319 · 2022-02-18

ApplicantViz. Ai, Inc.
Decision Date2022-02-18
Product CodeQFM
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Viz ANEURYSM, Viz ANX 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 2022-02-18 under 510(k) number K213319. The device is classified under product code QFM. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Viz ANEURYSM, Viz ANX?

Viz ANEURYSM, Viz ANX is a medical device that received FDA 510(k) clearance on 2022-02-18. The listed applicant is Viz. Ai, Inc.. The 510(k) number is K213319.

When did Viz ANEURYSM, Viz ANX receive FDA 510(k) clearance?

Viz ANEURYSM, Viz ANX received FDA 510(k) clearance on 2022-02-18, under 510(k) number K213319.

Who is the listed applicant for Viz ANEURYSM, Viz ANX?

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 ANEURYSM, Viz ANX?

The FDA product code for Viz ANEURYSM, Viz ANX is QFM.

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: QFM)

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.

K253751CXRDetectAINeurocareai, Inc. (Dba Savelife.Ai)K252954MammoSightAINeurocareai, Inc. (Dba Savelife.Ai)K252482CogNet AI-MT+Medcognetics, Inc.K250831Annalise EnterpriseAnnalise-AiK243808Rayvolve PTX-PEAZmedK243548BriefCase-TriageAidoc Medical , Ltd.

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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