SMART PCFD— 510(k) K250023

Substantially Equivalent

Disior, Ltd.

FDA 510(k) clearance K250023 for SMART PCFD, Substantially Equivalent on 2025-09-29. Applicant: Disior, Ltd..

Clearance details

Applicant: Disior, Ltd.
Product code: Code QIH
Advisory panel: Radiology
Date received: 2025-01-03
Decision date: 2025-09-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Helsinki Uusimaa, FI

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