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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
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