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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K022788
Device Name PHILIPS HARMONY RELEASE 1
Applicant
Philips Medical Systems North America Co.
22100 Bothell Everett Hwy
P.O. Box 3003
Bothell,  WA  98041 -3003
Applicant Contact LYNN T HARMER
Correspondent
Philips Medical Systems North America Co.
22100 Bothell Everett Hwy
P.O. Box 3003
Bothell,  WA  98041 -3003
Correspondent Contact LYNN T HARMER
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received08/22/2002
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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