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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 K101311
Device Name EP NAVIGATOR R3
Applicant
Philips Medical Systems North America Co.
22100 Bothell Everett Hwy.
P.O. Box 3003
Bothell,  WA  98041
Applicant Contact LYNN HARMER
Correspondent
Philips Medical Systems North America Co.
22100 Bothell Everett Hwy.
P.O. Box 3003
Bothell,  WA  98041
Correspondent Contact LYNN HARMER
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received05/11/2010
Decision Date 09/30/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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