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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 K223556
Device Name DeepCatch
Applicant
MEDICALIP Co., Ltd
SNUH Cancer Research Center 806, 101 Daehak-ro, Jongno-gu
Seoul,  KR 03080
Applicant Contact Jun-sik Yoon
Correspondent
GMS Consulting
4th Floor, Digital Cube, 34, Sangamsan-ro, Mapo-gu
Mapo-gu
Seoul,  KR 03909
Correspondent Contact Jong Hyun Kim
Regulation Number892.2050
Classification Product Code
QIH  
Date Received11/28/2022
Decision Date 06/16/2023
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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