FDA 510(k) Application Details - K233200

Device Classification Name	More FDA Info for this Device
510(K) Number	K233200
Device Name	XPLUS 35 Series (XPLUS 35, XPLUS 35FD)
Applicant	Gemss Healthcare Co., Ltd. 1F, 822, Bogwang-ro, Gwangtan-myeon Paju-si 10952 KR Other 510(k) Applications for this Company
Contact	Jiho Park Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OWB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/28/2023
Decision Date	11/16/2023
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