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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 K200274
Device Name CariCloud
Applicant
Caristo Diagnostics
New Barclay House, 234 Botley Road
Oxford,  GB OX20HP
Applicant Contact James Davis
Correspondent
Caristo Diagnostics
New Barclay House, 234 Botley Road
Oxford,  GB OX20HP
Correspondent Contact James Davis
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received02/04/2020
Decision Date 05/21/2020
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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