510(k) · Cleared
ClearedGammaBeam 500
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Best Theratronics Limited · IWB System, Radiation Therapy, Radionuclide
Cleared on Apr 17, 2015 as substantially equivalent to K863180 (Aecl Medical, 1986) after a 79-day review. Its family tree reaches back 1 generation to 1986.
- Decided
- Apr 17, 2015
- Review
- 79 days
- Class
- Class II
- Product code
- IWB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K863180 (1986). No later device cites it as a predicate yet.
- Root · 1 generation backK863180 Theratron-PhoenixAecl Medical · 1986 · Recalled
- This deviceK150191 GammaBeam 500Best Theratronics Limited · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K863180 | Theratron-Phoenix | Aecl Medical | 1986 | 1 |
| 0 (this device) | K150191 | GammaBeam 500 | Best Theratronics Limited | 2015 | — |
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 |
|---|---|---|---|
| * | K863180 | Theratron-PhoenixSummary page 4…Name GammaBeam 500 Common Name Cobalt Teletherapy Device Classification Name Radionuclide Radiation Therapy System Legally Marketed Predicate Device Theratron Phoenix (K863180) Device Classification Class I, 21 CFR 892.5750 Product Code IWB DESCRIPTION OF DEVICE The GammaBeam 500 is a radiotherapy tr… | 1986 |
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?
- Its one ancestor has a recall.
- 1 other device also cites its predicate K863180.
How does its category compare?
All IWB devicesIWB System, Radiation Therapy, Radionuclide: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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?
A Cobalt Teletherapy unit is a device by which gamma radiation is delivered for the
treatment of cancer under the direction of health care professionals in a radiation therapy
clinic.
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/K150191 · printed Nov 5, 2026
Cite this page
510(k) Report. “K150191: GammaBeam 500.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K150191
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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