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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 K212864
Device Name dS TorsoCardiac 1.5T, dS MSK S 1.5T, dS MSK M 1.5T
Applicant
Philips Healthcare (Suzhou) Co., Ltd
No.258, ZhongYuan Road, Suzhou Industrial Park
Suzhou,  CN 215024
Applicant Contact Seaman Shao
Correspondent
Philips Healthcare (Suzhou) Co., Ltd
No.258, ZhongYuan Road, Suzhou Industrial Park
Suzhou,  CN 215024
Correspondent Contact Seaman Shao
Regulation Number892.1000
Classification Product Code
MOS  
Date Received09/08/2021
Decision Date 12/01/2021
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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