HeartFlow Analysis— 510(k) K250902

Substantially Equivalent

HeartFlow, Inc.

FDA 510(k) clearance K250902 for HeartFlow Analysis, Substantially Equivalent on 2025-07-18. Applicant: HeartFlow, Inc..

Clearance details

Applicant: HeartFlow, Inc.
Product code: Code PJA
Advisory panel: Cardiovascular
Date received: 2025-03-26
Decision date: 2025-07-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mountain View, CA, US

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