Viz Subdural+, Viz SUBDURAL PLUS— 510(k) K250354

Substantially Equivalent

Viz. Ai, Inc.

FDA 510(k) clearance K250354 for Viz Subdural+, Viz SUBDURAL PLUS, Substantially Equivalent on 2025-06-10. 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: 2025-02-07
Decision date: 2025-06-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cary, NC, US

Download summary PDF View on FDA.gov ↗

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More clearances from Viz. Ai, Inc.

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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.