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..

Clearance details

Applicant: Viz. Ai, Inc.
Product code: Code QIH
Advisory panel: Radiology
Date received: 2025-02-07
Decision date: 2025-06-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cary, NC, US

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