FDA 510(k) Application Details - K243301

Device Classification Name	Accelerator, Linear, Medical   More FDA Info for this Device
510(K) Number	K243301
Device Name	Accelerator, Linear, Medical
Applicant	Vision RT Ltd Dove House, Arcadia Avenue London N3 2JU GB Other 510(k) Applications for this Company
Contact	Watheq Al-Hakam Other 510(k) Applications for this Contact
Regulation Number	892.5050   More FDA Info for this Regulation Number
Classification Product Code	IYE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/18/2024
Decision Date	05/19/2025
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