FDA 510(k) Application Details - K250665

Device Classification Name	Solid State X-Ray Imager (Flat Panel/Digital Imager)   More FDA Info for this Device
510(K) Number	K250665
Device Name	Solid State X-Ray Imager (Flat Panel/Digital Imager)
Applicant	KONICA MINOLTA, INC. 1 Sakura-machi Hino-shi Tokyo 1918511 JP Other 510(k) Applications for this Company
Contact	Makoto Sumi 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	03/05/2025
Decision Date	06/17/2025
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