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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 K230294
Device Name CoverScan (CoverScan v1.1)
Applicant
Perspectum
Gemini One
5220 John Smith Dr.
Oxford,  GB OX4 2LL
Applicant Contact Ioan Wigley
Correspondent
Perspectum
Gemini One
5220 John Smith Dr.
Oxford,  GB OX4 2LL
Correspondent Contact Ioan Wigley
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received02/02/2023
Decision Date 03/03/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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