FDA 510(k) Application Details - K151913

Device Classification Name System, Image Processing, Radiological

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510(K) Number K151913
Device Name System, Image Processing, Radiological
Applicant MIM Software Inc.
25800 Science Park Drive
SUITE 180
CLEVELAND, OH 44122 US
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Contact Lynn Hanigan
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Regulation Number 892.2050

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Classification Product Code LLZ
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Date Received 07/13/2015
Decision Date 04/25/2016
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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