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FDA 510(k) Application Details - K151924
Device Classification Name
System, X-Ray, Stationary
More FDA Info for this Device
510(K) Number
K151924
Device Name
System, X-Ray, Stationary
Applicant
QUANTUM MEDICAL IMAGING DIVISON OF CARESTREAM
2002-B ORVILLE DRIVE NORTH
RONKONKOMA, NY 11779 US
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Contact
MARK CAMIRAND
Other 510(k) Applications for this Contact
Regulation Number
892.1680
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Classification Product Code
KPR
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/13/2015
Decision Date
08/07/2015
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
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