PHILIPS HARMONY RELEASE 1


Device Classification Name

system, image processing, radiological

510(k) Number K022788
Device Name PHILIPS HARMONY RELEASE 1
Original Applicant
PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO.
22100 bothell everett hwy.
p.o. box 3003
bothell, 
WA 
98041 -3003

Original Contact lynn t harmer
Regulation Number 892.2050
Classification Product Code
LLZ  
Date Received 08/22/2002
Decision Date 10/25/2002
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