# K072898: Hexapod Evo RT Couch Top

- Pathway: 510(k) (Special)
- Applicant: Medical Intelligence Medizintechnik GmbH
- Decided: Oct 25, 2007 after 14 days
- Product code: JAI (Couch, Radiation Therapy, Powered)
- Device class: 2
- Regulation: 21 CFR 892.5770
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Medical Intelligence's HexaPOD RT Couch Top: named in the summary without a submission number

## Recalls of this device
- May 16, 2018 · Class II · Z-2535-2018: Upon completion of a 6D workflow, the HexaPOD evo Module may be in a tilted state if it is moved to the position used for 3D (non-iGUIDE) treatments resulting in incorrect patient positioning.
- Apr 17, 2014 · Class II · Z-1514-2014: If screws are not properly tightened with a torque wrench they may become loose over time.

## Indications for use
The intended use of the device is to support and aid in positioning a patient during radiation therapy.

Source page: https://510kreport.com/device/K072898
Methodology: https://510kreport.com/methodology