FDA 510(k) Application Details - K242994

Device Classification Name	More FDA Info for this Device
510(K) Number	K242994
Device Name	OncoStudio (OS-01)
Applicant	OncoSoft. Co., Ltd. 37, Myeongmul-gil, Seodaemun-gu Seoul 03776 KR Other 510(k) Applications for this Company
Contact	Boram Kim Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QKB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/26/2024
Decision Date	02/24/2025
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