FDA 510(k) Application Details - K142337

Device Classification Name System, Image Processing, Radiological

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510(K) Number K142337
Device Name System, Image Processing, Radiological
Applicant BLACKFORD ANALYSIS LTD
The Royal Observatory, Blackford Hill
EDINBURGH, Midlothian EH9 3hj GB
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Contact Gordon McNeilly
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Regulation Number 892.2050

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Classification Product Code LLZ
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Date Received 08/21/2014
Decision Date 03/19/2015
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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