Viz ICH— 510(k) K210209

Substantially Equivalent

Viz. Ai, Inc.

FDA 510(k) clearance K210209 for Viz ICH, Substantially Equivalent on 2021-03-23. Applicant: Viz. Ai, Inc.. Device class: 2.

Clearance details

Applicant: Viz. Ai, Inc.
Product code: Code QAS
Device class: Class 2
Regulation: 21 CFR 892.2080
Advisory panel: Radiology
Date received: 2021-01-26
Decision date: 2021-03-23
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.

K250354 — Viz Subdural+, Viz SUBDURAL PLUS2025-06-10
K232363 — Viz HDS, Viz Volume Plus, Viz ICH+2024-02-05
DEN230003 — Viz HCM2023-08-03
K223443 — Viz AAA2023-03-17
K223042 — Viz LVO ContaCT2022-10-21

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