HeartFocus— 510(k) K260780

Substantially Equivalent

Deski

FDA 510(k) clearance K260780 for HeartFocus, Substantially Equivalent on 2026-06-03. Applicant: Deski.

Clearance details

Applicant: Deski
Product code: Code QJU
Advisory panel: Radiology
Date received: 2026-03-10
Decision date: 2026-06-03
Decision: Substantially Equivalent
Clearance type: Special
Location: Bordeaux, FR

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