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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Tomography, Computed
510(k) Number K052447
Device Name SYNERAD IMPACT 60, SYNERAD IMPACT 72 AND ANALOGIC AMS1600
Applicant
Analogic Corp.
8 Centennial Dr.
Centennial Industrial Park
Peabody,  MA  01960
Applicant Contact DONALD SHERRATT
Correspondent
Intertek Testing Services
70 Codman Hill Rd.
Boxborough,  MA  01719
Correspondent Contact NEIL E DEVINE
Regulation Number892.1750
Classification Product Code
JAK  
Date Received09/07/2005
Decision Date 09/21/2005
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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