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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 K242096
Device Name dS FootAnkle Coil 8ch 1.5T
Applicant
Philips Medical Systems Nederland B.V.
Veenpluis 6
5684 Pc
Best,  NL
Applicant Contact Ketaki Bendre
Correspondent
Philips Medical Systems Nederland B.V.
Veenpluis 6
5684 Pc
Best,  NL
Correspondent Contact Ketaki Bendre
Regulation Number892.1000
Classification Product Code
MOS  
Date Received07/18/2024
Decision Date 08/12/2024
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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