FDA 510(k) Application Details - K223811

Device Classification Name	Analyzer,Medical Image   More FDA Info for this Device
510(K) Number	K223811
Device Name	Analyzer,Medical Image
Applicant	Imagen Technologies, Inc 594 Broadway, Suite 701 New York, NY 10012 US Other 510(k) Applications for this Company
Contact	Rebecca Jones, PhD 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	12/20/2022
Decision Date	09/13/2023
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