FDA 510(k) Application Details - K042791

Device Classification Name Solid State X-Ray Imager (Flat Panel/Digital Imager)

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510(K) Number K042791
Device Name Solid State X-Ray Imager (Flat Panel/Digital Imager)
Applicant ANN ARBOR DIGITAL DEVICES
699 SKYNOB COURT
ANN ARBOR, MI 48105 US
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Contact WILLIAM J O'NEILL
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Regulation Number 892.1650

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Classification Product Code MQB
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Date Received 10/07/2004
Decision Date 07/01/2005
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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