FDA 510(k) Application Details - K223556

Device Classification Name	More FDA Info for this Device
510(K) Number	K223556
Device Name	DeepCatch
Applicant	MEDICALIP Co., Ltd SNUH Cancer Research Center 806, 101 Daehak-ro, Jongno-gu Seoul 03080 KR Other 510(k) Applications for this Company
Contact	Jun-sik Yoon Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QIH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/28/2022
Decision Date	06/16/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review