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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radiological Image Processing Software For Radiation Therapy
510(k) Number K242994
Device Name OncoStudio (OS-01)
Applicant
OncoSoft. Co., Ltd.
37, Myeongmul-gil, Seodaemun-gu
Seoul,  KR 03776
Applicant Contact Boram Kim
Correspondent
OncoSoft. Co., Ltd.
37, Myeongmul-gil, Seodaemun-gu
Seoul,  KR 03776
Correspondent Contact Boram Kim
Regulation Number892.2050
Classification Product Code
QKB  
Date Received09/26/2024
Decision Date 02/24/2025
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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