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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 K070829
Device Name SYNEPIX 4600 DETECTOR
Applicant
Analogic Corporation
8 Centennial Dr.
Peabody,  MA  01960
Applicant Contact DONALD J SHERRATT
Correspondent
Analogic Corporation
8 Centennial Dr.
Peabody,  MA  01960
Correspondent Contact DONALD J SHERRATT
Regulation Number892.1680
Classification Product Code
MQB  
Date Received03/26/2007
Decision Date 05/09/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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