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FDA 510(k) Application Details - K150122
Device Classification Name
System, Image Processing, Radiological
More FDA Info for this Device
510(K) Number
K150122
Device Name
System, Image Processing, Radiological
Applicant
TOMTEC IMAGING SYSTEMS, GMBH
EDISONSTRASSE 6
UNTERSCHLEISSHEIM D-85716 DE
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Contact
CHRISTINE KLEIN
Other 510(k) Applications for this Contact
Regulation Number
892.2050
More FDA Info for this Regulation Number
Classification Product Code
LLZ
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More FDA Info for this Product Code
Date Received
01/20/2015
Decision Date
02/13/2015
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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