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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 K232021
Device Name Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5T
Applicant
Philips Healthcare (Suzhou) Co., Ltd.
No. 258, Zhongyuan Road
Suzhou Industrial Park
Suzhou,  CN 215024
Applicant Contact Li Sherry
Correspondent
Philips Healthcare (Suzhou) Co., Ltd.
No. 258, Zhongyuan Road
Suzhou Industrial Park
Suzhou,  CN 215024
Correspondent Contact Li Sherry
Regulation Number892.1000
Classification Product Code
MOS  
Date Received07/07/2023
Decision Date 09/01/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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