510(k) · Cleared
Recalled · 2006Table Tilt Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Brainlab AG · JAI Couch, Radiation Therapy, Powered
Cleared on May 14, 2004 as substantially equivalent to K031866 (Med-Tec,Inc., 2003) after a 212-day review. Its family tree reaches back 1 generation to 2003. It has been recalled once.
- Decided
- May 14, 2004
- Review
- 212 days
- Class
- Class II
- Product code
- JAI
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K031866 (2003). No later device cites it as a predicate yet.
- Root · 1 generation backK031866 Med-Tec 6 Degree Axis Couch, Model MT-6DACMed-Tec,Inc. · 2003
- This deviceK033316 Table Tilt DeviceBrainlab AG · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K031866 | Med-Tec 6 Degree Axis Couch, Model MT-6DAC | Med-Tec,Inc. | 2003 | — |
| 0 (this device) | K033316 | Table Tilt Device | Brainlab AG | 2004 | — |
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? (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 |
|---|---|---|---|
| * | K031866 | Med-Tec 6 Degree Axis Couch, Model MT-6DACSummary page 1…Robotic Tilt Module Common/Classification Name: Table Tilt Device Predicate Device: Med-Tec 6 degree axis couch, model MT-6DAC (K031866) Device Classification Name: Powered radiation therapy patient support assembly Regulatory Class: Class… | 2003 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 2, 2006 | Not classified | Z-1255-06 | Other | During ExacTrac Robotics installation on the Varian Exact Couch, the couch height position indication is re-calibrated to read out the correct positions. This re-calibration could cause the eventual failure of the vertical lift mechanism… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
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 Table Tilt Device is a device used to compensate rotational patient misalignment (roll and
pitch) in a linear accelerator environment for stereotactic radiosurgery or radiotherapy
procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033316 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033316: Table Tilt Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033316
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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