FDA 510(k) Application Details - K231995

Device Classification Name	System, X-Ray, Stationary   More FDA Info for this Device
510(K) Number	K231995
Device Name	System, X-Ray, Stationary
Applicant	Radmedix LLC 2510 Lance Dr Dayton, OH 45409 US Other 510(k) Applications for this Company
Contact	Gabriel Issa Other 510(k) Applications for this Contact
Regulation Number	892.1680   More FDA Info for this Regulation Number
Classification Product Code	KPR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/05/2023
Decision Date	10/25/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review