BrightHeart View Classifier— 510(k) K243684

Substantially Equivalent

Brightheart

FDA 510(k) clearance K243684 for BrightHeart View Classifier, Substantially Equivalent on 2025-05-07. Applicant: Brightheart.

Clearance details

Applicant: Brightheart
Product code: Code QIH
Advisory panel: Radiology
Date received: 2024-11-29
Decision date: 2025-05-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Paris, FR

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