FDA 510(k) Application Details - K974423

Device Classification Name	Screen, Intensifying, Radiographic   More FDA Info for this Device
510(K) Number	K974423
Device Name	Screen, Intensifying, Radiographic
Applicant	STERLING DIAGNOSTIC IMAGING, INC. P.O. BOX 19048 MAIL DROP 102 GREENVILLE, SC 29602-9048 US Other 510(k) Applications for this Company
Contact	JEAN E BARLETT Other 510(k) Applications for this Contact
Regulation Number	892.1960   More FDA Info for this Regulation Number
Classification Product Code	EAM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/24/1997
Decision Date	12/22/1997
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