FDA 510(k) Application Details - K212145

Device Classification Name	System, X-Ray, Fluoroscopic, Image-Intensified   More FDA Info for this Device
510(K) Number	K212145
Device Name	System, X-Ray, Fluoroscopic, Image-Intensified
Applicant	Agfa N.V. Septestraat 27 Mortsel B-2640 BE Other 510(k) Applications for this Company
Contact	Wim Govaerts Other 510(k) Applications for this Contact
Regulation Number	892.1650   More FDA Info for this Regulation Number
Classification Product Code	JAA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/09/2021
Decision Date	08/31/2021
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