FDA 510(k) Application Details - K213137

Device Classification Name	Accelerator, Linear, Medical   More FDA Info for this Device
510(K) Number	K213137
Device Name	Accelerator, Linear, Medical
Applicant	Carina Medical LLC 1233 Litchfield Ln Lexington, KY 40513 US Other 510(k) Applications for this Company
Contact	Xue Feng 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	09/27/2021
Decision Date	05/13/2022
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