FDA 510(k) Application Details - K222762

Device Classification Name	Accelerator, Linear, Medical   More FDA Info for this Device
510(K) Number	K222762
Device Name	Accelerator, Linear, Medical
Applicant	Panacea Medical Technologies Pvt Ltd Plot No. 35, 4th Phase, Malur KIADB Industrial Area Malur 563130 IN Other 510(k) Applications for this Company
Contact	Valli G. 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	09/13/2022
Decision Date	06/08/2023
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