FDA 510(k) Application Details - K243849

Device Classification Name	Full Field Digital,System,X-Ray,Mammographic   More FDA Info for this Device
510(K) Number	K243849
Device Name	Full Field Digital,System,X-Ray,Mammographic
Applicant	Rayence Co., Ltd 14, Samsung 1-ro 1-gil Hwaseong-si KR Other 510(k) Applications for this Company
Contact	Dong Hyeon Oh Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	MUE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/16/2024
Decision Date	03/12/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review