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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Nuclear Magnetic Resonance Imaging
510(k) Number K242573
Device Name NIDO Baby Magnetic Resonance Imaging System
Applicant
Jiangsu Lici Medical Device Co., Ltd.
277 Yuzhou S. Rd., Haizhou District
Jiangsu,  CN 222000
Applicant Contact Bing Keong Li
Correspondent
Zhihe Info-Tech(Suzhou) Co., Ltd.
Rm. 616, Bldg. 1, # 1 Huayun Rd.,
Industrial Park, Suzhou City
Jiangsu,  CN 215134
Correspondent Contact Rachel Yu
Regulation Number892.1000
Classification Product Code
LNH  
Date Received08/29/2024
Decision Date 12/23/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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