FDA 510(k) Application Details - K250850

Device Classification Name	System, X-Ray, Tomographic   More FDA Info for this Device
510(K) Number	K250850
Device Name	System, X-Ray, Tomographic
Applicant	Nano-x Imaging Ltd. 94 Em Hamoshavot Road, Brosh building, Ofer Tech Park, PO Box 3486 Petah Tikva 4970602 IL Other 510(k) Applications for this Company
Contact	Ofir Koren Other 510(k) Applications for this Contact
Regulation Number	892.1740   More FDA Info for this Regulation Number
Classification Product Code	IZF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/20/2025
Decision Date	04/16/2025
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