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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 K192372
Device Name ASCEND Image Viewer
Applicant
Ascend Hit
801 Warrenville Road Ste 200
Lisle,  IL  60532
Applicant Contact Andy Miller
Correspondent
Ascend Hit
801 Warrenville Road Ste 200
Lisle,  IL  60532
Correspondent Contact Andy Miller
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received08/30/2019
Decision Date 02/14/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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