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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
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