510(k) · Cleared
ClearedAdvanced Algorithms for Treatment Management Applications (AATMA)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Elekta Solutions AB · QKB Radiological Image Processing Software For Radiation Therapy
Cleared on Oct 25, 2021 as substantially equivalent to K181572 (Mirada Medical, Ltd., 2018) after a 101-day review. Its family tree reaches back 13 generations to 1991.
- Decided
- Oct 25, 2021
- Review
- 101 days
- Class
- Class II
- Product code
- QKB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 13 generations to K913770 (1991). 113 ancestors in all, the oldest K871859 (1987). No later device cites it as a predicate yet.
- Root · 13 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 9 generations between
- 3 generations backK102687 Mirada RTMirada Medical, Ltd. · 2010
- 2 generations backK130393 Mirada RTXMirada Medical, Ltd. · 2013
- 1 generation backK181572 Workflow BoxMirada Medical, Ltd. · 2018
- This deviceK212218 Advanced Algorithms for Treatment Management Applications (AATMA)Elekta Solutions AB · 2021
Show all 13 generations
- Root · 13 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 12 generations backK963345 Advantage Windows Tissue Volume OptionGE Medical Systems · 1996
- 11 generations backK013381 Advanced Lung Analysis-1General Electric Co. · 2001
- 10 generations backK022013 Lungcare CT Software PackageSiemens Medical Solutions USA, Inc. · 2002
- 9 generations backK033374 Lungcare CT Software Package with Extended FunctionalitySiemens AG Medical Solutions · 2003
- 8 generations backK041484 UndecidedSiemens Medical Solutions USA, Inc. · 2004
- 7 generations backK053301 Cedara I-Response Cedara Pet/CTCedara Software Corp. · 2006
- 6 generations backK071950 Syngo TruedSiemens Medical Solutions USA, Inc. · 2007
- 5 generations backK091373 Syngo TruedSiemens Medical Solutions USA, Inc. · 2009
- 4 generations backK101228 Mirada XDMirada Medical, Ltd. · 2010
- 3 generations backK102687 Mirada RTMirada Medical, Ltd. · 2010
- 2 generations backK130393 Mirada RTXMirada Medical, Ltd. · 2013
- 1 generation backK181572 Workflow BoxMirada Medical, Ltd. · 2018
- This deviceK212218 Advanced Algorithms for Treatment Management Applications (AATMA)Elekta Solutions AB · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −12 | K963345 | Advantage Windows Tissue Volume Option | GE Medical Systems | 1996 | — |
| −11 | K013381 | Advanced Lung Analysis-1 | General Electric Co. | 2001 | — |
| −10 | K022013 | Lungcare CT Software Package | Siemens Medical Solutions USA, Inc. | 2002 | — |
| −9 | K033374 | Lungcare CT Software Package with Extended Functionality | Siemens AG Medical Solutions | 2003 | — |
| −8 | K041484 | Undecided | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −7 | K053301 | Cedara I-Response Cedara Pet/CT | Cedara Software Corp. | 2006 | — |
| −6 | K071950 | Syngo Trued | Siemens Medical Solutions USA, Inc. | 2007 | — |
| −5 | K091373 | Syngo Trued | Siemens Medical Solutions USA, Inc. | 2009 | — |
| −4 | K101228 | Mirada XD | Mirada Medical, Ltd. | 2010 | — |
| −3 | K102687 | Mirada RT | Mirada Medical, Ltd. | 2010 | — |
| −2 | K130393 | Mirada RTX | Mirada Medical, Ltd. | 2013 | — |
| −1 | K181572 | Workflow Box | Mirada Medical, Ltd. | 2018 | — |
| 0 (this device) | K212218 | Advanced Algorithms for Treatment Management Applications (AATMA) | Elekta Solutions AB | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 4 | 0 |
| 1992 | 2 | 0 |
| 1993 | 2 | 0 |
| 1994 | 3 | 0 |
| 1995 | 4 | 0 |
| 1996 | 5 | 0 |
| 1997 | 4 | 0 |
| 1998 | 7 | 0 |
| 1999 | 3 | 0 |
| 2000 | 9 | 0 |
| 2001 | 13 | 0 |
| 2002 | 11 | 0 |
| 2003 | 7 | 0 |
| 2004 | 10 | 0 |
| 2005 | 4 | 0 |
| 2006 | 3 | 0 |
| 2007 | 4 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QKB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new QKB device
- #1 K191928 AccuContourscore 32.8 · 14 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K181572 | Workflow BoxSummary page 4…sing System Regulation Number: 21 CFR § 892.2050 Product Code: QKB/LLZ III. PREDICATE DEVICE Workflow Box by Mirada Medical (K181572) IV. DEVICE DESCRIPTION AATMA™ is an optional accessory to treatment planning systems and intermediate pre-trea… | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 30 years and passes through 7 companies; a new generation was cleared every 1.5 years on median.
- 25 of the 113 ancestors have a recall of any class.
- 5 other devices also cite its predicate K181572.
How does its category compare?
All QKB devicesQKB Radiological Image Processing Software For Radiation Therapy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · QKB
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QKB
170in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QKB
No recall names QKB since 2007.
Adverse event reports per year · QKB
No MAUDE report names QKB since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 4 | 244 | 0 | 0 |
| 2021 | 9 | 120 | 0 | 0 |
| 2022 | 7 | 162 | 0 | 0 |
| 2023 | 7 | 111 | 0 | 0 |
| 2024 | 6 | 173 | 0 | 0 |
| 2025 | 6 | 170 | 0 | 0 |
| 2026 | 9 | 179 | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K212218 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212218: Advanced Algorithms for Treatment Management Applications (AATMA).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212218
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026