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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 K212565
Device Name CoverScan v1
Applicant
Perspectum, Ltd.
5520 John Smith Dr.
Oxford,  GB OX4 2LL
Applicant Contact Ioan Wigley
Correspondent
Perspectum, Ltd.
5520 John Smith Dr.
Oxford,  GB OX4 2LL
Correspondent Contact Ioan Wigley
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received08/13/2021
Decision Date 05/19/2022
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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