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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Automated Radiological Image Processing Software
510(k) Number K253614
Device Name EchoNavigator R5.0
Applicant
Philips Medical Systems Nederland B.V.
Veenpluis 6
Best,  NL 5684PC
Applicant Contact Yesheshvi Anush Puvvada
Correspondent
Philips Medical Systems Nederland B.V.
Veenpluis 6
Best,  NL 5684PC
Correspondent Contact Yesheshvi Anush Puvvada
Regulation Number892.2050
Classification Product Code
QIH  
Subsequent Product Code
LLZ  
Date Received11/18/2025
Decision Date 03/17/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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