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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 Rd., #02-00
Singapore,  SG 94080
Applicant Contact James Hare
Correspondent
Enzyme Corporation
611 Gateway Blvd.
Suite 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
Predetermined Change
Control Plan Authorized		 No
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