FDA 510(k) Application Details - K152639

Device Classification Name	Solid State X-Ray Imager (Flat Panel/Digital Imager)   More FDA Info for this Device
510(K) Number	K152639
Device Name	Solid State X-Ray Imager (Flat Panel/Digital Imager)
Applicant	AGFA HEALTHCARE N.V. SEPTESTRAAT 27 MORTSEL B 2640 BE Other 510(k) Applications for this Company
Contact	Koren Vervoort Other 510(k) Applications for this Contact
Regulation Number	892.1650   More FDA Info for this Regulation Number
Classification Product Code	MQB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/15/2015
Decision Date	12/11/2015
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