FDA 510(k) Application Details - K163203

Device Classification Name	System, X-Ray, Stationary   More FDA Info for this Device
510(K) Number	K163203
Device Name	System, X-Ray, Stationary
Applicant	Carestream Health, Inc. 150 Verona Street Rochester, NY 14608 US Other 510(k) Applications for this Company
Contact	Carolyn L. Wagner Other 510(k) Applications for this Contact
Regulation Number	892.1680   More FDA Info for this Regulation Number
Classification Product Code	KPR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/15/2016
Decision Date	12/13/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review