FDA 510(k) Application Details - K122536

Device Classification Name System, Image Processing, Radiological

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510(K) Number K122536
Device Name System, Image Processing, Radiological
Applicant LIN & ASSOCIATES, LLC.
9223 CAMBRIDGE MANOR COURT
POTOMAC, MD 20854 US
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Contact CHIU S LIN
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Regulation Number 892.2050

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Classification Product Code LLZ
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Date Received 08/20/2012
Decision Date 10/03/2013
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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