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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 K002100
Device Name XIMX SYSTEM
Applicant
Medical Manager Research Development
555 Thirteenth St., NW
Washington,  DC  20004 -1109
Applicant Contact JEFFREY K SHAPIRO
Correspondent
Medical Manager Research Development
555 Thirteenth St., NW
Washington,  DC  20004 -1109
Correspondent Contact JEFFREY K SHAPIRO
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received07/11/2000
Decision Date 08/25/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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