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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer
510(k) Number K202300
Device Name Optellum Virtual Nodule Clinic, Optellum software, Optellum platform
Applicant
Optellum, Ltd.
Oxford Centre For Innovation
New Rd.
Oxford,  GB OX1 1BY
Applicant Contact David Arrowsmith
Correspondent
Optellum, Ltd.
Oxford Centre For Innovation
New Rd.
Oxford,  GB OX1 1BY
Correspondent Contact David Arrowsmith
Regulation Number892.2060
Classification Product Code
POK  
Date Received08/13/2020
Decision Date 03/05/2021
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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