FDA 510(k) Application Details - K161984

Device Classification Name	Accelerator, Linear, Medical   More FDA Info for this Device
510(K) Number	K161984
Device Name	Accelerator, Linear, Medical
Applicant	AKTINA MEDICAL CORPORATION 360 NORTH ROUTE 9W CONGERS, NY 10920 US Other 510(k) Applications for this Company
Contact	TONY SPACCAROTELLA 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	07/19/2016
Decision Date	09/27/2016
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