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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 K052938
Device Name CR-PRO
Applicant
Eradlink, Inc.
22750 Hawthorne Blvd.
Torrance,  CA  90505 -3664
Applicant Contact ALBERT KOUBA
Correspondent
Intertek Testing Services
70 Codman Hill Rd.
Boxborough,  MA  01719
Correspondent Contact DANIEL W LEHTONEN
Regulation Number892.1680
Classification Product Code
MQB  
Date Received10/20/2005
Decision Date 11/17/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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