FDA 510(k) Application Details - K213353

Device Classification Name	Analyzer,Medical Image   More FDA Info for this Device
510(K) Number	K213353
Device Name	Analyzer,Medical Image
Applicant	Imagen Technologies, Inc 151 West 26th Street, Suite 1001 New York, NY 10001 US Other 510(k) Applications for this Company
Contact	Robert Lindsey Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	MYN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/08/2021
Decision Date	09/20/2022
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