FDA 510(k) Application Details - K180809

Device Classification Name	Solid State X-Ray Imager (Flat Panel/Digital Imager)   More FDA Info for this Device
510(K) Number	K180809
Device Name	Solid State X-Ray Imager (Flat Panel/Digital Imager)
Applicant	Carestream Health, Inc 150 Verona Street Rochester, NY 14608 US Other 510(k) Applications for this Company
Contact	Diane Koetter 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	03/28/2018
Decision Date	06/21/2018
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