FDA 510(k) Application Details - K203744

Device Classification Name	More FDA Info for this Device
510(K) Number	K203744
Device Name	Arterys MICA
Applicant	Arterys Inc. 51 Federal Street, Suite 305 San Francisco, CA 94107 US Other 510(k) Applications for this Company
Contact	Sharon Cholowsky Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QIH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/22/2020
Decision Date	03/14/2022
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