FDA 510(k) Application Details - K213857

Device Classification Name	More FDA Info for this Device
510(K) Number	K213857
Device Name	HeartFlow Analysis
Applicant	HeartFlow, Inc. 1400 Seaport Boulevard, Building B Redwood City, CA 94063 US Other 510(k) Applications for this Company
Contact	Windi Hary 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	12/10/2021
Decision Date	10/14/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review