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FDA 510(k) Application Details - K123520
Device Classification Name
Full Field Digital,System,X-Ray,Mammographic
More FDA Info for this Device
510(K) Number
K123520
Device Name
Full Field Digital,System,X-Ray,Mammographic
Applicant
SIEMENS MEDICAL SOLUTIONS USA, INC.
51 VALLEY STREAM PKWY.
MALVERN, PA 19355-1406 US
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Contact
PATRICIA D JONES
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Regulation Number
000.0000
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Classification Product Code
MUE
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/15/2012
Decision Date
06/11/2013
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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