510(k) · Cleared
Recalled · 2004Theratron Elite
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Theratronics, Inc. · IWB System, Radiation Therapy, Radionuclide
Cleared on Dec 4, 1998 as substantially equivalent to K964606 (Theratronics, Inc., 1997) and 1 other predicate after a 30-day review. Its family tree reaches back 2 generations to 1990. 1 later device descends from it. It has been recalled 2 times.
- Decided
- Dec 4, 1998
- Review
- 30 days
- Class
- Class II
- Product code
- IWB
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 2 generations to K894165 (1990). 4 ancestors in all, the oldest K850543 (1985). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK894165 Theratron 1000Theratronics, Inc. · 1990
- 1 generation backK964607 Theraton 1000ETheratronics, Inc. · 1997 · Recalled
- This deviceK983917 Theratron EliteTheratronics, Inc. · 1998
- Descendant · cites it directly · 0 of its ownK053485 Theratron Equinox, Models 80 CM and 100 CMMds Nordion, Inc. · 2006
Most influential descendants
Showing 1 of 1 · See all- K053485Theratron Equinox, Models 80 CM and 100 CMMds Nordion, Inc. · 2006 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K894165 | Theratron 1000 | Theratronics, Inc. | 1990 | — |
| −1 | K964607 | Theraton 1000E | Theratronics, Inc. | 1997 | 1 |
| 0 (this device) | K983917 | Theratron Elite | Theratronics, Inc. | 1998 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 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? (2)
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 |
|---|---|---|---|
| * | K964606 | Theratron 780ESummary page 1…v 16, 1998 Trade name: Theratron Elite Common name: Cobalt Teletherapy device Classif. name: Radionuclide Radiation Therapy System Equivalent device: Theratron 780E (K964606), Theratron 1000E (K964607). Description of device: The Theratron Elite consists of a source head, collimator, gantry, main fra… | 1997 |
| * | K964607 | Theraton 1000ESummary page 1…ratron Elite Common name: Cobalt Teletherapy device Classif. name: Radionuclide Radiation Therapy System Equivalent device: Theratron 780E (K964606), Theratron 1000E (K964607). Description of device: The Theratron Elite consists of a source head, collimator, gantry, main frame, base, controls and a pe… | 1997 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K053485 | Theratron Equinox, Models 80 CM and 100 CM | 2006 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 8, 2004 | Not classified | Z-1183-06 | Other | The source locking device may not fit properly through the smaller opening in the new field light shield which could prevent the source from being returned manually under emergency conditions. |
| Jul 8, 2004 | Not classified | Z-1184-06 | Other | The source locking device may not fit properly through the smaller opening in the new field light shield which could prevent the source from being returned manually under emergency conditions. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 8 years and passes through 1 company; a new generation was cleared every 7.3 years on median.
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K053485 (Mds Nordion, Inc., 2006) 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.
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 device is intended to be used in:
Delivering the intended dose of radiation at a specified position;
Delivering the radiation in accordance with the selected relationship of the radiation to the patient (fixed or moving beam therapy, beam modifying device, etc);
Delivering the radiation without causing unnecessary risk to the patient, the operator, other persons or the immediate environment.
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/K983917 · printed Nov 4, 2026
Cite this page
510(k) Report. “K983917: Theratron Elite.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K983917
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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