FDA 510(k) Application Details - K250902

Device Classification Name	More FDA Info for this Device
510(K) Number	K250902
Device Name	HeartFlow Analysis
Applicant	HeartFlow, Inc. 331 E. Evelyn Avenue Mountain View, CA 94041 US Other 510(k) Applications for this Company
Contact	Kristen DeJeu Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PJA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/26/2025
Decision Date	07/18/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review