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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 K260519
Device Name Smart Fit TorsoCardiac 1.5T
Applicant
Philips Healthcare (Suzhou) Co., Ltd.
# 258, Zhongyuan Rd., Suzhou Industrial Park, Suzhou Jiangsu
Suzhou,  CN 215024
Applicant Contact Sherry Li
Correspondent
Philips Healthcare (Suzhou) Co., Ltd.
# 258, Zhongyuan Rd., Suzhou Industrial Park, Suzhou Jiangsu
Suzhou,  CN 215024
Correspondent Contact Sherry Li
Regulation Number892.1000
Classification Product Code
MOS  
Date Received02/17/2026
Decision Date 03/20/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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