FDA 510(k) Application Details - K041581

Device Classification Name System, Image Processing, Radiological

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510(K) Number K041581
Device Name System, Image Processing, Radiological
Applicant INTELLIGENT IMAGES SRL
VIALE CEMBRANO 4C/4
GENOVA (GE) I-16148 IT
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Contact MAURIZIO PAIGGIO
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Regulation Number 892.2050

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Classification Product Code LLZ
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Date Received 06/14/2004
Decision Date 06/22/2004
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 Y
Expedited Review



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