FDA 510(k) Application Details - K081630

Device Classification Name System, Image Processing, Radiological

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510(K) Number K081630
Device Name System, Image Processing, Radiological
Applicant IMAGE DIAGNOST INTERNATIONAL GMBH
BALANSTR. 57
MUENCHEN 81541 DE
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Contact PETER HEINLEIN
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Regulation Number 892.2050

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Classification Product Code LLZ
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Date Received 06/11/2008
Decision Date 07/29/2008
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 Y
Expedited Review



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