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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Coil, Magnetic Resonance, Specialty
510(k) Number K262330
Device Name dS Breast 7ch 1.5TdS Breast 7ch 3.0TdS Breast 16ch 1.5TdS Breast 16ch 3.0TdS Breast Coil 7ch 1.5TdS Sentinelle Breast 16ch 1.5TdS Sentinelle Breast 16ch 3.0T
Applicant
Philips Medical Systems Nederland B.V.
Veenpluis 6, 5684 Pc Best
Best,  NL 5684PC
Applicant Contact Ketaki Bendre
Correspondent
Philips Medical Systems Nederland B.V.
Veenpluis 6
Best,  NL 5684 PC
Correspondent Contact Ketaki Bendre
Regulation Number892.1000
Classification Product Code
MOS  
Date Received07/09/2026
Decision Date 07/30/2026
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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