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FDA 510(k) Application Details - K090552
Device Classification Name
System, Image Processing, Radiological
More FDA Info for this Device
510(K) Number
K090552
Device Name
System, Image Processing, Radiological
Applicant
NEUSOFT MEDICAL SYSTEMS CO., LTD.
NO. 16, SHIJI ROAD
HUNNAN INDUSTRIAL AREA
SHENYANG, LIAONING 110179 CN
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Contact
TIAN YANFANG
Other 510(k) Applications for this Contact
Regulation Number
892.2050
More FDA Info for this Regulation Number
Classification Product Code
LLZ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/02/2009
Decision Date
03/16/2009
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
Y
Expedited Review
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