FDA 510(k) Application Details - K223133

Device Classification Name	Analyzer,Medical Image   More FDA Info for this Device
510(K) Number	K223133
Device Name	Analyzer,Medical Image
Applicant	Imidex Inc. 3513 Brighton Blvd., Suites 456 7 454 Denver, CO 80216 US Other 510(k) Applications for this Company
Contact	Kris Zeschin 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	10/03/2022
Decision Date	08/03/2023
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