FDA 510(k) Application Details - K211542

Device Classification Name	Solid State X-Ray Imager (Flat Panel/Digital Imager)   More FDA Info for this Device
510(K) Number	K211542
Device Name	Solid State X-Ray Imager (Flat Panel/Digital Imager)
Applicant	A.T.S. Applicazione Tecnologie Speciali S.R.L. Via Alessandro Volta, 10 Torre De Roveri 24060 IT Other 510(k) Applications for this Company
Contact	Livia Pillitteri 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	05/19/2021
Decision Date	07/09/2021
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