FDA 510(k) Application Details - K041484

Device Classification Name System, Image Processing, Radiological

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510(K) Number K041484
Device Name System, Image Processing, Radiological
Applicant SIEMENS MEDICAL SOLUTIONS USA, INC.
51 VALLEY STREAM PKWY.
MALVERN, PA 19355-1406 US
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Contact RICHARD K ANDERSEN
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Regulation Number 892.2050

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Classification Product Code LLZ
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Date Received 06/04/2004
Decision Date 07/30/2004
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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