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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 K052661
Device Name QUIX DIGITAL RADIOGRAPHIC UPGRADE
Original Applicant
EDGE MEDICAL DEVICES LTD.
25 hatasiya
raanana,  IS 43654
Original Contact vered scharf
Regulation Number892.1680
Classification Product Code
MQB  
Date Received09/27/2005
Decision Date 06/07/2006
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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