# K190978: RefleXion Medical Radiotherapy System

- Pathway: 510(k) (Traditional)
- Applicant: Reflexion Medical, Inc.
- Decided: Mar 12, 2020 after 332 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- 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: 11 generations back to K914698 (1992). 27 ancestors in all.
No later device cites it as a predicate yet.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121934: Tomotherapy Treatment System, Accuray Incorporated (2012) Summary page 4.

## Recalls of this device
- Nov 24, 2021 · Class II · Z-0470-2022: Due to dose discrepancy when delivering a plan to a patient in a Non-HFS (Head First Supine) orientation specifically in Feet First Supine (FFS).

## Indications for use
The RefleXion Medical Radiotherapy System is indicated for treatment planning and precise delivery of image-guided radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery for tumors or other targeted tissues anywhere in the body when radiation treatment is indicated, while minimizing the delivery of radiation to vital healthy tissue. The megavoltage X-ray radiation is delivered in a rotational, modulated, image-guided format in accordance with the physician approved plan.

Source page: https://510kreport.com/device/K190978
Methodology: https://510kreport.com/methodology