FDA 510(k) Application Details - K032748

Device Classification Name System, Image Processing, Radiological

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510(K) Number K032748
Device Name System, Image Processing, Radiological
Applicant VITAL IMAGES, INC.
3300 FERNBROOK LN. NORTH
SUITE 200
PLYMOUTH, MN 55447 US
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Contact STEPHEN S ANDERSON
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Regulation Number 892.2050

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Classification Product Code LLZ
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Date Received 09/05/2003
Decision Date 10/29/2003
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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