FDA 510(k) Application Details - K223425

Device Classification Name	System, Image Processing, Radiological   More FDA Info for this Device
510(K) Number	K223425
Device Name	System, Image Processing, Radiological
Applicant	MDAI Inc 110 Wall Street New York, NY 10005 US Other 510(k) Applications for this Company
Contact	Leon Chen Other 510(k) Applications for this Contact
Regulation Number	892.2050   More FDA Info for this Regulation Number
Classification Product Code	LLZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/14/2022
Decision Date	02/10/2023
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