ULTRASIM CT SYSTEM


definition

Device Classification Name

system, x-ray, tomography, computed

510(k) Number K001088
Device Name ULTRASIM CT SYSTEM
Original Applicant
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
595 miner rd.
cleveland, 
OH 
44143

Original Contact robert l turocy
Regulation Number 892.1750
Classification Product Code
JAK  
Date Received 04/04/2000
Decision Date 06/22/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls