Viz HDS, Viz Volume Plus, Viz ICH+— 510(k) K232363

Name: FDA 510(k) clearance K232363
Creator: U.S. Food and Drug Administration
Published: 2024-02-05

Substantially Equivalent

Viz. Ai, Inc.

FDA 510(k) clearance K232363 for Viz HDS, Viz Volume Plus, Viz ICH+, Substantially Equivalent on 2024-02-05. Applicant: Viz. Ai, Inc.. Device class: 2.

Clearance details

Applicant: Viz. Ai, Inc.
Product code: Code QIH
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2023-08-07
Decision date: 2024-02-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Francisco, CA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Viz. Ai, Inc.

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K250354 — Viz Subdural+, Viz SUBDURAL PLUS2025-06-10
DEN230003 — Viz HCM2023-08-03
K223443 — Viz AAA2023-03-17
K223042 — Viz LVO ContaCT2022-10-21
K221100 — Viz RV/LV2022-08-29

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