Advanced Algorithms for Treatment Management Applications (AATMA)— 510(k) K212218

Substantially Equivalent

Elekta Solutions AB

FDA 510(k) clearance K212218 for Advanced Algorithms for Treatment Management Applications (AATMA), Substantially Equivalent on 2021-10-25. Applicant: Elekta Solutions AB. Device class: 2.

Clearance details

Applicant
Elekta Solutions AB
Product code
Code QKB
Device class
Class 2
Regulation
21 CFR 892.2050
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Stockholm, SE
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