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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 K210791
Device Name Us2.v1
Applicant
eko.ai Pte. Ltd. d/b/a Us2.ai
2 College Road, #02-00
Singapore,  SG 94080
Applicant Contact James Hare
Correspondent
Enzyme Corporation
611 Gateway Blvd Ste 120
South San Francisco,  CA  94080
Correspondent Contact Jared Seehafer
Regulation Number892.2050
Classification Product Code
QIH  
Date Received03/16/2021
Decision Date 07/27/2021
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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