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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
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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