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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 K131873
Device Name NDOHD HIGH DEFINITION IMAGING SYSTEM (NDOHD)
Applicant
MethodSense, Inc.
P.O. Box 110352
Durham,  NC  27709
Applicant Contact RITA KING
Correspondent
MethodSense, Inc.
P.O. Box 110352
Durham,  NC  27709
Correspondent Contact RITA KING
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received06/24/2013
Decision Date 09/25/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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