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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 K173744
Device Name ProFuse CAD
Applicant
Eigen
16633 Grass Valley Ave.
Grass Valley,  CA  95945
Applicant Contact William Mandel
Correspondent
Eigen
13366 Grass Valley Ave.
Grass Valley,  CA  95945
Correspondent Contact William Mandel
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received12/07/2017
Decision Date 11/21/2018
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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