FDA 510(k) Application Details - K250970

Device Classification Name	System, X-Ray, Tomography, Computed   More FDA Info for this Device
510(K) Number	K250970
Device Name	System, X-Ray, Tomography, Computed
Applicant	Leo Cancer Care 7921 UW Health Court Middleton, WI 53562 US Other 510(k) Applications for this Company
Contact	Nickie Power Other 510(k) Applications for this Contact
Regulation Number	892.1750   More FDA Info for this Regulation Number
Classification Product Code	JAK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/31/2025
Decision Date	07/25/2025
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