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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Automated Radiological Image Processing Software
510(k) Number K223501
Device Name ViewFinder Software Version 1.1
Applicant
Elaitra Ltd
8B Buckland Crescent, Belsize Park
London,  GB NW3 5DX
Applicant Contact Stephen Morrell
Correspondent
Elaitra Ltd
8B Buckland Crescent, Belsize Park
London,  GB NW3 5DX
Correspondent Contact Stephen Morrell
Regulation Number892.2050
Classification Product Code
QIH  
Date Received11/21/2022
Decision Date 04/21/2023
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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