FDA 510(k) Application Details - K973131

Device Classification Name System, Digital Image Communications, Radiological

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510(K) Number K973131
Device Name System, Digital Image Communications, Radiological
Applicant SIEMENS MEDICAL SOLUTIONS USA, INC.
186 WOOD AVENUE SOUTH
ISELIN, NJ 08830 US
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Contact AMY SHAW HOSLER
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Regulation Number 892.2020

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Classification Product Code LMD
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Date Received 08/21/1997
Decision Date 11/12/1997
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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