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510(k) K212218

Advanced Algorithms for Treatment Management Applications (AATMA) by Elekta Solutions AB — Product Code QKB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 25, 2021
Date Received
July 16, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radiological Image Processing Software For Radiation Therapy
Device Class
Class II
Regulation Number
892.2050
Review Panel
RA
Submission Type

To provide semi-automatic or fully-automated radiological image processing and analysis tools for radiation therapy. Software implementing artificial intelligence (AI) including nonadaptive machine learning algorithms trained with clinical and/or artificial radiological images. In these devices, the algorithm training images typically impact device performance. AI based radiological image processing software is intended to be used in the workflow of radiation therapy. Adaptive AI algorithms are not within the scope of this product code. Primary radiation dose calculation or plan optimization for treatment planning are not within scope of this product code.

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