FDA 510(k) Application Details - K201172

Device Classification Name	More FDA Info for this Device
510(K) Number	K201172
Device Name	CFP-3131, CFP-2222
Applicant	MX Imaging, Inc. 2894 Columbia Street Torrance, CA 90503 US Other 510(k) Applications for this Company
Contact	John Ross Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OWB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/01/2020
Decision Date	05/29/2020
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