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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
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