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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K991626
Device Name WEBRAD COMPUTED RADIOGRAPHY QUALITY ASSURANCE WORKSTATION
Applicant
Analogic Corp.
8 Centennial Dr.
Peabody,  MA  01960
Applicant Contact GARET VAN GENNEP
Correspondent
Analogic Corp.
8 Centennial Dr.
Peabody,  MA  01960
Correspondent Contact GARET VAN GENNEP
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received05/11/1999
Decision Date 07/02/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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