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FDA 510(k) Application Details - K061671
Device Classification Name
System, Image Processing, Radiological
More FDA Info for this Device
510(K) Number
K061671
Device Name
System, Image Processing, Radiological
Applicant
SIEMENS MEDICAL SOLUTIONS
20 VALLEY STREAM PARKWAY
MALVERN, PA 19355 US
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Contact
JAMES E KUHN
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
06/14/2006
Decision Date
06/29/2006
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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