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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
Applicant
Edge Medical Devices , Ltd.
25 Hatasiya
Raanana,  IL 43654
Applicant Contact VERED SCHARF
Correspondent
Edge Medical Devices , Ltd.
25 Hatasiya
Raanana,  IL 43654
Correspondent Contact VERED SCHARF
Regulation Number892.1680
Classification Product Code
MQB  
Date Received09/27/2005
Decision Date 06/07/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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