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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 K042821
Device Name DIGITAL DETECTOR, MODEL GR17
Applicant
Anrad Corp.
8 Centennial Dr.
Peabody,  MA  01960
Applicant Contact DONALD J SHERRATT
Correspondent
Intertek Testing Services
2307 E. Aurora Rd.
Unit B7
Twinsburg,  OH  44087
Correspondent Contact DANIEL W LEHTONEN
Regulation Number892.1680
Classification Product Code
MQB  
Date Received10/12/2004
Decision Date 10/22/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Abbreviated
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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