FDA 510(k) Application Details - K233196

Device Classification Name	More FDA Info for this Device
510(K) Number	K233196
Device Name	Medihub Prostate
Applicant	JLK Inc. 11F, 5, Teheran-ro 33-gil, Gangnam-gu Seoul 06141 KR Other 510(k) Applications for this Company
Contact	Dongmin Kim 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	09/28/2023
Decision Date	06/21/2024
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