FDA 510(k) Application Details - K973206

Device Classification Name	Solid State X-Ray Imager (Flat Panel/Digital Imager)   More FDA Info for this Device
510(K) Number	K973206
Device Name	Solid State X-Ray Imager (Flat Panel/Digital Imager)
Applicant	STERLING DIAGNOSTIC IMAGING, INC. P.O. BOX 6101 BUILDING 600/MAILBOX 630 NEWARK, DE 19714-6101 US Other 510(k) Applications for this Company
Contact	ELAINE H KINDELL 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	08/26/1997
Decision Date	12/04/1997
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