FDA 510(k) Application Details - K242573

Device Classification Name System, Nuclear Magnetic Resonance Imaging

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510(K) Number K242573
Device Name System, Nuclear Magnetic Resonance Imaging
Applicant Jiangsu LiCi Medical Device Co., Ltd.
277 Yuzhou South Road, Haizhou District
Jiangsu 222000 CN
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Contact Bing Keong Li
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Regulation Number 892.1000

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Classification Product Code LNH
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Date Received 08/29/2024
Decision Date 12/23/2024
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review

FDA Source Information for K242573


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