510(k) · Cleared
ClearedAkesis Galaxy RTx
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Akesis, Inc. · IWB System, Radiation Therapy, Radionuclide
Cleared on Feb 4, 2020 as substantially equivalent to K190844 (Akesis, Inc., 2019) after a 25-day review. Its family tree reaches back 2 generations to 1997. 2 later devices descend from it.
- Decided
- Feb 4, 2020
- Review
- 25 days
- Class
- Class II
- Product code
- IWB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K970647 (1997). 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK970647 Our Rotating Gamma SystemOur Scientific Intl., Inc. · 1997
- 1 generation backK190844 Akesis GalaxyAkesis, Inc. · 2019
- This deviceK200050 Akesis Galaxy RTxAkesis, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK203250 TaiChiCOur United Corporation · 2021
- Descendant · cites it directly · 0 of its ownK203146 Akesis Galaxy RTiAkesis, Inc. · 2021
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K970647 | Our Rotating Gamma System | Our Scientific Intl., Inc. | 1997 | — |
| −1 | K190844 | Akesis Galaxy | Akesis, Inc. | 2019 | — |
| 0 (this device) | K200050 | Akesis Galaxy RTx | Akesis, Inc. | 2020 | — |
| +1 | K203250 | TaiChiC | Our United Corporation | 2021 | — |
| +1 | K203146 | Akesis Galaxy RTi | Akesis, Inc. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 2 | 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 IWB? 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 IWB device
- #1 K250391 Leksell Gamma Knife® (Elekta Esprit); Leksell…score 11.2 · 13 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 |
|---|---|---|---|
| * | K190844 | Akesis GalaxySummary page 4…IWB Common/Usual Name: Radionuclide radiation therapy system III. PREDICATE DEVICE Akesis Galaxy Rotating Gamma System (K190844) IV. DEVICE DESCRIPTION The Akesis Galaxy RTx, is a medical teletherapy device, which contains… | 2019 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 23 years and passes through 2 companies; a new generation was cleared every 22.3 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K203250 (Our United Corporation, 2021) has gone furthest, with 0 descendants of its own.
How does its category compare?
All IWB devicesIWB System, Radiation Therapy, Radionuclide: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · IWB
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IWB
57in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IWB
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IWB
3in 2025
MAUDE reports naming product code IWB, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 3 | 8 |
| 2008 | 0 | — | 3 | 15 |
| 2009 | 1 | — | 1 | 8 |
| 2010 | 0 | — | 1 | 9 |
| 2011 | 1 | — | 2 | 5 |
| 2012 | 1 | — | 0 | 3 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 3 | 170 | 1 | 8 |
| 2015 | 3 | 79 | 0 | 5 |
| 2016 | 1 | — | 0 | 7 |
| 2017 | 1 | — | 0 | 4 |
| 2018 | 3 | 57 | 0 | 2 |
| 2019 | 1 | — | 0 | 3 |
| 2020 | 1 | — | 0 | 2 |
| 2021 | 2 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 1 | 1 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Akesis Galaxy RTx Gamma System, is a teletherapy device intended for the stereotactic irradiation of human head structures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200050 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200050: Akesis Galaxy RTx.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200050
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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