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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
Best,  NL 5684 PC
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 Received07/18/2024
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
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