FDA 510(k) Application Details - K212218

Device Classification Name	More FDA Info for this Device
510(K) Number	K212218
Device Name	Advanced Algorithms for Treatment Management Applications (AATMA)
Applicant	Elekta Solutions AB Kungstensgatan 18 Box 7593 Stockholm SE10393 SE Other 510(k) Applications for this Company
Contact	Melinda Smith Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QKB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/16/2021
Decision Date	10/25/2021
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