510(k) · Cleared
Recalled · 2004Theraton 1000E
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Theratronics, Inc. · IWD Device, Beam Limiting, Teletherapy, Radionuclide
Cleared on May 28, 1997 as substantially equivalent to K894165 (Theratronics, Inc., 1990) after a 191-day review. Its family tree reaches back 1 generation to 1990. 2 later devices descend from it. It has been recalled once.
- Decided
- May 28, 1997
- Review
- 191 days
- Class
- Class II
- Product code
- IWD
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K894165 (1990). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK894165 Theratron 1000Theratronics, Inc. · 1990
- This deviceK964607 Theraton 1000ETheratronics, Inc. · 1997
- Descendant · cites it directly · 1 of its ownK983917 Theratron EliteTheratronics, Inc. · 1998 · Recalled
- Descendant · 2 generations on · 0 of its ownK053485 Theratron Equinox, Models 80 CM and 100 CMMds Nordion, Inc. · 2006
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 |
|---|---|---|---|---|---|
| −1 | K894165 | Theratron 1000 | Theratronics, Inc. | 1990 | — |
| 0 (this device) | K964607 | Theraton 1000E | Theratronics, Inc. | 1997 | — |
| +1 | K983917 | Theratron Elite | Theratronics, Inc. | 1998 | 2 |
| +2 | K053485 | Theratron Equinox, Models 80 CM and 100 CM | Mds Nordion, Inc. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 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 IWD? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K894165 | Theratron 1000Summary page 1…ame: Theratron 1000E Common name: Cobalt Teletherapy device Classification name: Radionuclide Radiation Therapy System Equivalent device: Theratron 1000, 510(k) number K894165/B. Description of device: The Theratron 1000E consists of a source head, collimator, gantry, main frame, base, controls and a p… | 1990 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K983917 | Theratron Elite | 1998 | 1 |
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-1181-06 | 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?
- Its one ancestor has no recall.
- Of its descendants, K983917 (Theratronics, Inc., 1998) has gone furthest, with 1 descendant of its own.
How does its category compare?
All IWD devicesIWD Device, Beam Limiting, Teletherapy, Radionuclide: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IWD
FDA has decided no IWD device since 2007.
Median 510(k) review, days · IWD
Too few IWD 510(k)s in any year since 2007 to give a median.
Recalls per year · IWD
No recall names IWD since 2007.
Adverse event reports per year · IWD
1in 2009
MAUDE reports naming product code IWD, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 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/K964607 · printed Nov 6, 2026
Cite this page
510(k) Report. “K964607: Theraton 1000E.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K964607
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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