FDA 510(k) Application Details - K244010

Device Classification Name	Solid State X-Ray Imager (Flat Panel/Digital Imager)   More FDA Info for this Device
510(K) Number	K244010
Device Name	Solid State X-Ray Imager (Flat Panel/Digital Imager)
Applicant	JPI Healthcare Co, Ltd 608-ho, 28, Digital-ro 33 gil, Guro-gu Seoul 08377 KR Other 510(k) Applications for this Company
Contact	Jeongjoon Lee Other 510(k) Applications for this Contact
Regulation Number	892.1650   More FDA Info for this Regulation Number
Classification Product Code	MQB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/26/2024
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