FDA 510(k) Application Details - K151353

Device Classification Name System, Image Processing, Radiological

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510(K) Number K151353
Device Name System, Image Processing, Radiological
Applicant SIEMENS MEDICAL SOLUTIONS USA, INC.
51 VALLEY STREAM PARKWAY
MAVERN, PA 19355 US
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Contact CORDELL L. FIELDS
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Regulation Number 892.2050

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Classification Product Code LLZ
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Date Received 05/20/2015
Decision Date 08/07/2015
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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