FDA 510(k) Application Details - K171467

Device Classification Name	Accelerator, Linear, Medical   More FDA Info for this Device
510(K) Number	K171467
Device Name	Accelerator, Linear, Medical
Applicant	Focal Therapeutics 1010 Stewart Drive Sunnyvale, CA 94085 US Other 510(k) Applications for this Company
Contact	George Hermann 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	05/18/2017
Decision Date	11/09/2017
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