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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 K060035
Device Name MDXNET
Applicant
Cybermdx, Inc.
Richmond Sq.
Suite 166w
Providence,  RI  02906
Applicant Contact JOHN COLEMAN
Correspondent
Cybermdx, Inc.
Richmond Sq.
Suite 166w
Providence,  RI  02906
Correspondent Contact JOHN COLEMAN
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received01/05/2006
Decision Date 03/09/2006
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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