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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 K230209
Device Name Sonix Health
Applicant
Ontact Health Co., Ltd.
5f, 50-5, Ewhayeodae-Gil, Seodaemun-Gu
Seoul,  KR KS013/03764
Applicant Contact Hyuk-Jae Chang
Correspondent
Ontact Health Co., Ltd.
5f, 50-5, Ewhayeodae-Gil, Seodaemun-Gu
Seoul,  KR KS013/03764
Correspondent Contact Hyuk-Jae Chang
Regulation Number892.2050
Classification Product Code
QIH  
Subsequent Product Code
LLZ  
Date Received01/25/2023
Decision Date 10/20/2023
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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