PHILIPS INTEGRIS ALLURA FLAT DETECTOR RELEASE 1.0


Device Classification Name

system, x-ray, fluoroscopic, image-intensified

510(k) Number K022899
Device Name PHILIPS INTEGRIS ALLURA FLAT DETECTOR RELEASE 1.0
Original Applicant
PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO.
22100 bothell everett hwy.
p.o. box 3003
bothell, 
WA 
98041 -3003

Original Contact lynn harmer
Regulation Number 892.1650
Classification Product Code
JAA  
Subsequent Product Code
IZI  
Date Received 09/03/2002
Decision Date 11/22/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls