FDA 510(k) Application Details - K991535

Device Classification Name	System, Tomography, Computed, Emission   More FDA Info for this Device
510(K) Number	K991535
Device Name	System, Tomography, Computed, Emission
Applicant	HITACHI MEDICAL CORP. OF AMERICA 9177 DUTTON DR. TWINSBURG, OH 44056 US Other 510(k) Applications for this Company
Contact	GARY W ENOS Other 510(k) Applications for this Contact
Regulation Number	892.1200   More FDA Info for this Regulation Number
Classification Product Code	KPS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/03/1999
Decision Date	07/30/1999
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