# K231612: Eve Patient Positioner System

- Pathway: 510(k) (Traditional)
- Applicant: Leo Cancer Care
- Decided: May 7, 2024 after 340 days
- Product code: JAI (Couch, Radiation Therapy, Powered)
- Device class: 2
- Regulation: 21 CFR 892.5770
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K042146 (2004). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160518: LEONI ORION System, Leoni Cia Cable System (2016) Summary page 4.

## Indications for use
The Leo Cancer Care Patient Positioning Subsystem is indicated for precise positioning of human patients to facilitate delivery of external beam radiation when integrated with a separate beam therapy treatment delivery device.

Source page: https://510kreport.com/device/K231612
Methodology: https://510kreport.com/methodology