510(k) · Cleared
Recalled · Class II · 2015Elekta Oncology Systems Precise Treatment Table
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Elekta Instruments, Inc. · JAI Couch, Radiation Therapy, Powered
Cleared on Jan 15, 1999 after an 87-day review. The FDA summary names its predicate without a number. 2 later devices descend from it. It has been recalled 4 times.
- Decided
- Jan 15, 1999
- Review
- 87 days
- Class
- Class II
- Product code
- JAI
- Recalls
- 4
- Predicates
- 0
2 later devices descend from it, 2 citing it directly.
- This deviceK983678 Elekta Oncology Systems Precise Treatment TableElekta Instruments, Inc. · 1999
- Descendant · cites it directly · 0 of its ownK060870 AvanzaMds Nordion · 2006
- Descendant · cites it directly · 0 of its ownK032248 Precise Carbon Fiber Table Top, Model 11-999Aktina Medical Physics Corp. · 2003
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 |
|---|---|---|---|---|---|
| 0 (this device) | K983678 | Elekta Oncology Systems Precise Treatment Table | Elekta Instruments, Inc. | 1999 | — |
| +1 | K060870 | Avanza | Mds Nordion | 2006 | — |
| +1 | K032248 | Precise Carbon Fiber Table Top, Model 11-999 | Aktina Medical Physics Corp. | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 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 JAI? 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 JAI device
- #1 K231612 Eve Patient Positioner Systemscore 7.9 · 3 generations · no Class I recall
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 |
|---|---|---|---|
| * | — | Eos Ram Named without a submission number | |
| * | — | Pedestal Named without a submission number |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 29, 2015 | Class II | Z-1238-2015 | Radiation Control for Health and Safety Act | It is possible to position the Treatment Table with errors greater than 5mm and no inhibits are displayed, if the positional sensors are not correctly installed during corrective maintenance. Clinical mistreatment may occur if a position… |
| Mar 14, 2013 | Class II | Z-1072-2013 | Device Design | The Column rotation can accidentally be moved to a different position which in the locked position. |
| Mar 10, 2008 | Not classified | Z-1030-2011 | Other | Possible error in the table longitudinal position. |
| Jan 11, 2007 | Not classified | Z-1432-2010 | Other | In some instances, the bolts which are supplied with the table have sheared off, resulting in inability to operate the powered table. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K060870 (Mds Nordion, 2006) has gone furthest, with 0 descendants of its own.
How does its category compare?
All JAI devicesJAI Couch, Radiation Therapy, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JAI
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · JAI
61in 2012
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JAI
2in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JAI
1in 2024
MAUDE reports naming product code JAI, 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 | 2 | — | 1 | 4 |
| 2008 | 0 | — | 2 | 2 |
| 2009 | 0 | — | 1 | 3 |
| 2010 | 0 | — | 2 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 4 | 61 | 0 | 2 |
| 2013 | 1 | — | 2 | 5 |
| 2014 | 0 | — | 0 | 2 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 1 | — | 0 | 2 |
| 2017 | 1 | — | 1 | 3 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 2 | 0 |
| 2024 | 1 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Precise™ Treatment Table is intended as a universal patient treatment support and positioning table for radiation therapy and simulation use. It is for use with existing Elekta Linear Accelerators and Simulators and adaptable to third party radiotherapy products.
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/K983678 · printed Nov 4, 2026
Cite this page
510(k) Report. “K983678: Elekta Oncology Systems Precise Treatment Table.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K983678
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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