FDA 510(k) Application Details - K223234

Device Classification Name	Accelerator, Linear, Medical   More FDA Info for this Device
510(K) Number	K223234
Device Name	Accelerator, Linear, Medical
Applicant	ScandiDos AB Dag Hammarskj÷lds vΣg 52A Uppsala 752 37 SE Other 510(k) Applications for this Company
Contact	Daniel Pederson 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	10/19/2022
Decision Date	01/16/2024
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