FDA 510(k) Application Details - K982631

Device Classification Name	System, X-Ray, Tomography, Computed   More FDA Info for this Device
510(K) Number	K982631
Device Name	System, X-Ray, Tomography, Computed
Applicant	PHILIPS MEDICAL SYSTEMS, INC. 710 BRIDGEPORT AVE. P.O. BOX 860 SHELTON, CT 06484 US Other 510(k) Applications for this Company
Contact	FRANK GIANELLI Other 510(k) Applications for this Contact
Regulation Number	892.1750   More FDA Info for this Regulation Number
Classification Product Code	JAK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/28/1998
Decision Date	10/06/1998
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