# K250970: Marie

- Pathway: 510(k) (Traditional)
- Applicant: Leo Cancer Care
- Decided: Jul 25, 2025 after 116 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K930090 (1993). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160611: P-Artis, P-Cure, Ltd. (2016) Summary page 5.

## Indications for use
The Marie Imaging System is indicated for the acquisition of CT images and the precise positioning of human patients to facilitate delivery of external beam radiation when integrated with a separate therapy treatment delivery device.

Source page: https://510kreport.com/device/K250970
Methodology: https://510kreport.com/methodology