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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 K151941
Device Name DEXIS Webview
Applicant
Imaging Sciences International /Gendex/Dexis
1910 N. Penn Rd.
Hatfield,  PA  19440
Applicant Contact Sanjay Ahuja
Correspondent
Imaging Sciences International /Gendex/Dexis
1910 N. Penn Rd.
Hatfield,  PA  19440
Correspondent Contact Sanjay Ahuja
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received07/14/2015
Decision Date 10/07/2015
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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