# K212218: Advanced Algorithms for Treatment Management Applications (AATMA)

- Pathway: 510(k) (Traditional)
- Applicant: Elekta Solutions AB
- Decided: Oct 25, 2021 after 101 days
- Product code: QKB (Radiological Image Processing Software For Radiation Therapy)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K913770 (1991). 113 ancestors in all.
No later device cites it as a predicate yet.
0 of 114 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181572: Workflow Box, Mirada Medical, Ltd. (2018) Summary page 4.

## Indications for use
AATMA™ is a medical image processing library intended to produce derived data sets for use as input into radiation therapy treatment planning systems or other intermediate pre-treatment-planning applications. AATMA™ does not provide a user interface and is designed to be accessed through its application programming interface (API) by other devices. The data sets created by AATMA™ must be reviewed and validated by a qualified healthcare professional prior to clinical use.

Source page: https://510kreport.com/device/K212218
Methodology: https://510kreport.com/methodology