FDA 510(k) Application Details - K183272

Device Classification Name System, Image Processing, Radiological

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510(K) Number K183272
Device Name System, Image Processing, Radiological
Applicant Siemens Medical Solutions USA, Inc.
40 Liberty Blvd.
Malvern, PA 19355 US
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Contact Kimberly Mangum
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Regulation Number 892.2050

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Classification Product Code LLZ
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Date Received 11/23/2018
Decision Date 02/01/2019
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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