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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 K221270
Device Name EchoNavigator R4.0
Applicant
Philips Medical Systems Nederland B.V.
Veenpluis 6
5684 Pc
Best,  NL
Applicant Contact Supriya A. Dalvi
Correspondent
Philips Medical Systems Nederland B.V.
Veenpluis 6
5684 Pc
Best,  NL
Correspondent Contact Supriya A. Dalvi
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received05/02/2022
Decision Date 05/31/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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