Brain WMH— 510(k) K251527

Substantially Equivalent

Quantib B.V.

FDA 510(k) clearance K251527 for Brain WMH, Substantially Equivalent on 2025-09-25. Applicant: Quantib B.V..

Clearance details

Applicant: Quantib B.V.
Product code: Code QIH
Advisory panel: Radiology
Date received: 2025-05-19
Decision date: 2025-09-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rotterdam, NL

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