FDA 510(k) Application Details - K061132

Device Classification Name System, Nuclear Magnetic Resonance Imaging

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510(K) Number K061132
Device Name System, Nuclear Magnetic Resonance Imaging
Applicant NEUSOFT MEDICAL SYSTEMS CO., LTD.
NO.3-11, WENHUA ROAD
HEPING DISTRICT
SHENYANG, LIAONING 110004 CN
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Contact TIAN YANFANG
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Regulation Number 892.1000

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Classification Product Code LNH
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Date Received 04/24/2006
Decision Date 05/24/2006
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review

FDA Source Information for K061132


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