FDA 510(k) Application Details - K031704

Device Classification Name System, Image Processing, Radiological

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510(K) Number K031704
Device Name System, Image Processing, Radiological
Applicant CONNECT IMAGING, INC.
850 WEST HIND DRIVE # 214
HONOLULU, HI 96821 US
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Contact PHILIP J MANLY
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Regulation Number 892.2050

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Classification Product Code LLZ
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Date Received 06/02/2003
Decision Date 07/31/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Statement
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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