510(k) · Cleared
ClearedTheratron Equinox, Models 80 CM and 100 CM
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mds Nordion, Inc. · IWB System, Radiation Therapy, Radionuclide
Cleared on Mar 9, 2006 as substantially equivalent to K983917 (Theratronics, Inc., 1998) after an 84-day review. Its family tree reaches back 3 generations to 1990.
- Decided
- Mar 9, 2006
- Review
- 84 days
- Class
- Class II
- Product code
- IWB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K894165 (1990). 5 ancestors in all, the oldest K850543 (1985). No later device cites it as a predicate yet.
- Root · 3 generations backK894165 Theratron 1000Theratronics, Inc. · 1990
- 2 generations backK964607 Theraton 1000ETheratronics, Inc. · 1997 · Recalled
- 1 generation backK983917 Theratron EliteTheratronics, Inc. · 1998 · Recalled
- This deviceK053485 Theratron Equinox, Models 80 CM and 100 CMMds Nordion, Inc. · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K894165 | Theratron 1000 | Theratronics, Inc. | 1990 | — |
| −2 | K964607 | Theraton 1000E | Theratronics, Inc. | 1997 | 1 |
| −1 | K983917 | Theratron Elite | Theratronics, Inc. | 1998 | 2 |
| 0 (this device) | K053485 | Theratron Equinox, Models 80 CM and 100 CM | Mds Nordion, Inc. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1997 | 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 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 |
|---|---|---|---|
| * | K983917 | Theratron EliteSummary page 1…, or the immediate environment. Summary of Technological Characteristics The Theratron Equinox 80 and 100 is substantially equivalent to the predicate device (k983917). The design change is to provide a new 'modern' appearance to the previous design using existing major components of t… | 1998 |
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 16 years and passes through 2 companies; a new generation was cleared every 7.3 years on median.
- 3 of the 5 ancestors have a recall of any class.
How does its category compare?
All IWB devicesIWB System, Radiation Therapy, Radionuclide: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 as stated in the FDA summary.
https://510kreport.com/device/K053485 · printed Nov 5, 2026
Cite this page
510(k) Report. “K053485: Theratron Equinox, Models 80 CM and 100 CM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K053485
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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