FDA 510(k) Application Details - K243171

Device Classification Name	Solid State X-Ray Imager (Flat Panel/Digital Imager)   More FDA Info for this Device
510(K) Number	K243171
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	April Cheng 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	09/30/2024
Decision Date	12/19/2024
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