FDA 510(k) Application Details - K973411

Device Classification Name	Digitizer, Image, Radiological   More FDA Info for this Device
510(K) Number	K973411
Device Name	Digitizer, Image, Radiological
Applicant	GENERAL SCANNING, INC. 500 ARSENAL ST. WATERTOWN, MA 02172 US Other 510(k) Applications for this Company
Contact	WALTER J LESLIE Other 510(k) Applications for this Contact
Regulation Number	892.2030   More FDA Info for this Regulation Number
Classification Product Code	LMA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/09/1997
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