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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 K233676
Device Name Us2.v2
Applicant
Eko.ai Pte. Ltd d/b/a Us2.ai
2 College Road, #02-00
Singapore,  SG
Applicant Contact Hui Qun Tay
Correspondent
Eko.ai Pte. Ltd d/b/a Us2.ai
2 College Road, #02-00
Singapore,  SG
Correspondent Contact Hui Qun Tay
Regulation Number892.2050
Classification Product Code
QIH  
Date Received11/16/2023
Decision Date 04/01/2024
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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