FDA 510(k) Application Details - K973413

Device Classification Name	Device, Digital Image Storage, Radiological   More FDA Info for this Device
510(K) Number	K973413
Device Name	Device, Digital Image Storage, Radiological
Applicant	I.S.G. TECHNOLOGIES, INC. 6509 AIRPORT ROAD MISSISSAUGA, ONTARIO L4V 1S7 CA Other 510(k) Applications for this Company
Contact	CAROL NAKAGAWA 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	09/09/1997
Decision Date	11/25/1997
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