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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 K243033
Device Name dS Wrist coil 8ch 1.5T
Applicant
Philips Medical Systems Nederland BV
Veenpluis 6, 5684 Pc Best
Best,  NL 5684PC
Applicant Contact Sherry Li
Correspondent
Philips Medical Systems Nederland BV
Veenpluis 6, 5684 Pc Best
Best,  NL 5684PC
Correspondent Contact Sherry Li
Regulation Number892.1000
Classification Product Code
MOS  
Date Received09/27/2024
Decision Date 10/18/2024
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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