FDA 510(k) Application Details - K970628

Device Classification Name	System, Digital Image Communications, Radiological   More FDA Info for this Device
510(K) Number	K970628
Device Name	System, Digital Image Communications, Radiological
Applicant	GE MEDICAL SYSTEMS, INC. P.O. BOX 414 MILWAUKEE, WI 53201 US Other 510(k) Applications for this Company
Contact	LARRY A KROGER, PH.D. Other 510(k) Applications for this Contact
Regulation Number	892.2020   More FDA Info for this Regulation Number
Classification Product Code	LMD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/19/1997
Decision Date	05/12/1997
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