# K221230: TRON

- Pathway: 510(k) (Traditional)
- Applicant: Xoran Technologies, LLC
- Decided: Jul 28, 2022 after 90 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K003266 (2000). 10 ancestors in all.
No later device cites it as a predicate yet.
1 of 11 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200074: O-arm O2 Imaging System, Medtronic, Inc. (2020) Summary page 4.

## Indications for use
TRON is a mobile X-Ray imaging system with fluoroscopy and tomography capability that is intended to be used for anatomy that can safely fit within the device gantry and positioned within the imaging aperture (such as the head, neck, chest, abdomen, and extremities: arm, wrist, hand, leg, knee, ankle, and foot).

Source page: https://510kreport.com/device/K221230
Methodology: https://510kreport.com/methodology