510(k) · Cleared
ClearedTaiChiC
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Our United Corporation · IWB System, Radiation Therapy, Radionuclide
Cleared on Mar 12, 2021 as substantially equivalent to K200050 (Akesis, Inc., 2020) after a 128-day review. Its family tree reaches back 3 generations to 1997.
- Decided
- Mar 12, 2021
- Review
- 128 days
- Class
- Class II
- Product code
- IWB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K970647 (1997). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 |
|---|---|---|---|
| * | K200050 | Akesis Galaxy RTxSummary page 4…Device Regulation: 21 CFR 892.5750 Regulatory Class: II Product Code: IWB III. PREDICATE DEVICE Primary Device Akesis Galaxy RTx (K200050) Classification Name: Radionuclide radiation therapy system Device Regulation: 21 CFR 892.5750 Regulatory Cla… | 2020 |
| † | K193207 | TaiChiA | 2020 |
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 24 years and passes through 3 companies; a new generation was cleared every 1.1 years on median.
- None of the 3 ancestors has a recall.
- 1 other device also cites its predicate K200050.
How does its category compare?
All IWB devicesIWB System, Radiation Therapy, Radionuclide: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 system is a teletherapy device intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions in the brain and head where radiation treatment is indicated.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K203250 · printed Nov 5, 2026
Cite this page
510(k) Report. “K203250: TaiChiC.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K203250
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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