Viz ANEURYSM, Viz ANX— 510(k) K213319

Substantially Equivalent

Viz. Ai, Inc.

FDA 510(k) clearance K213319 for Viz ANEURYSM, Viz ANX, Substantially Equivalent on 2022-02-18. Applicant: Viz. Ai, Inc.. Device class: 2.

Clearance details

Applicant: Viz. Ai, Inc.
Product code: Code QFM
Device class: Class 2
Regulation: 21 CFR 892.2080
Advisory panel: Radiology
Date received: 2021-10-04
Decision date: 2022-02-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Francisco, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code QFM

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Data sourced from openFDA. This site is unofficial and independent of the FDA.