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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name solid state x-ray imager (flat panel/digital imager)
510(k) Number K042791
Device Name INSTANT-X, MODELS 1713 & 128
Applicant
ANN ARBOR DIGITAL DEVICES
699 SKYNOB COURT
ANN ARBOR,  MI  48105
Applicant Contact WILLIAM J O'NEILL
Correspondent
ANN ARBOR DIGITAL DEVICES
699 SKYNOB COURT
ANN ARBOR,  MI  48105
Correspondent Contact WILLIAM J O'NEILL
Regulation Number892.1680
Classification Product Code
MQB  
Date Received10/07/2004
Decision Date 07/01/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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