BRIGHTVIEW VCT IMAGING SYSTEM


Device Classification Name

system, tomography, computed, emission

510(k) Number K080927
Device Name BRIGHTVIEW VCT IMAGING SYSTEM
Applicant
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
540 alder drive
milpitas, 
CA 
95035

Applicant Contact coleen a coleman
Regulation Number 892.1200
Classification Product Code
KPS  
Date Received 04/02/2008
Decision Date 04/11/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No

Recalls CDRH Recalls