FDA 510(k) Application Details - K071636

Device Classification Name System, Image Processing, Radiological

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510(K) Number K071636
Device Name System, Image Processing, Radiological
Applicant IVS SOLUTIONS AG
ANNABERGET STRASSE 240
CHEMNITZ, SAXONY 09125 DE
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Contact FRANK STOCKMANN
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Regulation Number 892.2050

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Classification Product Code LLZ
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Date Received 06/15/2007
Decision Date 08/09/2007
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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