FDA 510(k) Application Details - K243057

Device Classification Name	System,Planning,Radiation Therapy Treatment   More FDA Info for this Device
510(K) Number	K243057
Device Name	System,Planning,Radiation Therapy Treatment
Applicant	Adaptiiv Medical Technologies, Inc. 1969 Upper Water Street, Suite 906 Halifax B3J 3R7 CA Other 510(k) Applications for this Company
Contact	Olga Zhuk Other 510(k) Applications for this Contact
Regulation Number	892.5050   More FDA Info for this Regulation Number
Classification Product Code	MUJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/27/2024
Decision Date	10/23/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review