FDA 510(k) Application Details - K250211

Device Classification Name	Solid State X-Ray Imager (Flat Panel/Digital Imager)   More FDA Info for this Device
510(K) Number	K250211
Device Name	Solid State X-Ray Imager (Flat Panel/Digital Imager)
Applicant	InnoCare Optoelectronics Corp. Rm. B, No. 2, Sec. 2, Huanxi Rd., Southern Taiwan Science Park, Xinshi Dist. Tainan 741 TW Other 510(k) Applications for this Company
Contact	Christy Huang 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	01/24/2025
Decision Date	07/22/2025
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