FDA 510(k) Application Details - K131391

Device Classification Name System, Image Processing, Radiological

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510(K) Number K131391
Device Name System, Image Processing, Radiological
Applicant NANJING JUSHA DISPLAY TECHNOLOGY CO., LTD
7TH FLOOR, 982. CONGYUN RD. BAIYUN DISTRICT
GUANGZHOU, GUANGDONG CH510420 CN
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Contact MIKE GU
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Regulation Number 892.2050

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Classification Product Code LLZ
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Date Received 05/14/2013
Decision Date 08/21/2013
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



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