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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
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