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FDA 510(k) Application Details - K142341
Device Classification Name
System, X-Ray, Fluoroscopic, Image-Intensified
More FDA Info for this Device
510(K) Number
K142341
Device Name
System, X-Ray, Fluoroscopic, Image-Intensified
Applicant
SHIMADZU CORP.
1 NISHINOKYO-KUWABARACHO
NAKAYGO-KU
KYOTO 604-8511 JP
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Contact
TOSHIO KADOWAKI
Other 510(k) Applications for this Contact
Regulation Number
892.1650
More FDA Info for this Regulation Number
Classification Product Code
JAA
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/21/2014
Decision Date
03/06/2015
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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