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FDA 510(k) Application Details - K082430
Device Classification Name
System, Image Processing, Radiological
More FDA Info for this Device
510(K) Number
K082430
Device Name
System, Image Processing, Radiological
Applicant
SIEMENS AG, MEDICAL SOLUTIONS
HENKESTRASSE 127
ERLANGEN 91052 DE
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Contact
SABINE SCHROEDEL
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
08/22/2008
Decision Date
11/14/2008
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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