FDA 510(k) Application Details - K193243

Device Classification Name	Accelerator, Linear, Medical   More FDA Info for this Device
510(K) Number	K193243
Device Name	Accelerator, Linear, Medical
Applicant	Qfix 440 Church Road Avondale, PA 19311 US Other 510(k) Applications for this Company
Contact	Alexandra Low Smythe 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	11/25/2019
Decision Date	02/28/2020
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