FDA 510(k) Application Details - K212233

Device Classification Name	System, Nuclear Magnetic Resonance Imaging   More FDA Info for this Device
510(K) Number	K212233
Device Name	System, Nuclear Magnetic Resonance Imaging
Applicant	HeartVista, Inc. 2625 Middlefield Rd, #710 Palo Alto, CA 94306 US Other 510(k) Applications for this Company
Contact	James J Rogers Other 510(k) Applications for this Contact
Regulation Number	892.1000   More FDA Info for this Regulation Number
Classification Product Code	LNH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/16/2021
Decision Date	10/05/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review