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FDA 510(k) Application Details - K111642
Device Classification Name
System, Image Processing, Radiological
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510(K) Number
K111642
Device Name
System, Image Processing, Radiological
Applicant
TRANSLATIONAL SCIENCES CORPORATION
ONE MIFFLIN PLACE
SUITE 400
CAMBRIDGE, MA 02138 US
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Contact
ALLEN GREEN, MD, PHD, JD
Other 510(k) Applications for this Contact
Regulation Number
892.2050
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Classification Product Code
LLZ
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More FDA Info for this Product Code
Date Received
06/13/2011
Decision Date
11/18/2011
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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