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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 K222757
Device Name Clarus Viewer
Applicant
Clarus Viewer Corporation
5030 Bradford Dr. Nw; Bldg. 2, Suite 104
Huntsville,  AL  35805
Applicant Contact Steve Thomas
Correspondent
Kapstone Medical, LLC
520 Elliot St.
Charlotte,  NC  28202
Correspondent Contact Carolyn Guthrie
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received09/12/2022
Decision Date 02/24/2023
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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