# K033316: Table Tilt Device

- Pathway: 510(k) (Traditional)
- Applicant: Brainlab AG
- Decided: May 14, 2004 after 212 days
- Product code: JAI (Couch, Radiation Therapy, Powered)
- Device class: 2
- Regulation: 21 CFR 892.5770
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K031866 (2003). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031866: Med-Tec 6 Degree Axis Couch, Model MT-6DAC, Med-Tec,Inc. (2003) Summary page 1.

## Recalls of this device
- Jun 2, 2006 · Not classified · Z-1255-06: 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 f

## Indications for use
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.

Source page: https://510kreport.com/device/K033316
Methodology: https://510kreport.com/methodology