FDA 510(k) Application Details - K951942

Device Classification Name	Device, Digital Image Storage, Radiological   More FDA Info for this Device
510(K) Number	K951942
Device Name	Device, Digital Image Storage, Radiological
Applicant	INSIGHT SYSTEMS 14 SUNSET RIDGE DR. POMONA, CA 91766 US Other 510(k) Applications for this Company
Contact	DONALD R MAXWELL Other 510(k) Applications for this Contact
Regulation Number	892.2010   More FDA Info for this Regulation Number
Classification Product Code	LMB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/26/1995
Decision Date	04/08/1996
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review