ALLEGRO IMAGING SYSTEM

Device Classification Name

system, tomography, computed, emission

510(k) Number K033782
Device Name ALLEGRO IMAGING SYSTEM
Applicant
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
595 miner rd.
cleveland, 
OH 
44143

Applicant Contact christof littwitz
Regulation Number 892.1200
Classification Product Code
KPS  
Date Received 12/04/2003
Decision Date 12/19/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No