FDA 510(k) Application Details - K061326

Device Classification Name System, Image Processing, Radiological

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510(K) Number K061326
Device Name System, Image Processing, Radiological
Applicant BARCOVIEW MIS EDINBURGH
BONNINGTON BOND, 2 ANDERSON PL
EDINBURGH, LOTHIAN EH6 5NP GB
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Contact NEIL PHILLIPS
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Regulation Number 892.2050

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Classification Product Code LLZ
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Date Received 05/10/2006
Decision Date 05/25/2006
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 Y
Expedited Review



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