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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 K161959
Device Name ClearView cCAD
Applicant
ClearView Diagnostics Inc.
371 Hoes Lane, Suite 205
Piscataway,  NJ  08854
Applicant Contact Christine Podilchuk
Correspondent
ClearView Diagnostics Inc.
371 Hoes Lane, Suite 205
Piscataway,  NJ  08854
Correspondent Contact Christine Podilchuk
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received07/18/2016
Decision Date 12/28/2016
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
Recalls CDRH Recalls
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