FDA 510(k) Application Details - K024028

Device Classification Name System, Image Processing, Radiological

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510(K) Number K024028
Device Name System, Image Processing, Radiological
Applicant CONTEXT VISION AB
STORGATAN 24
LINKOPING SE-582 23 SE
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Contact KENT STRANDLUND
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Regulation Number 892.2050

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Classification Product Code LLZ
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Date Received 12/06/2002
Decision Date 01/24/2003
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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