# K243446: 3DXR

- Pathway: 510(k) (Traditional)
- Applicant: GE Medical Systems SCS
- Decided: Feb 25, 2025 after 111 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: 13 generations back to K890348 (1989). 60 ancestors in all.
No later device cites it as a predicate yet.
0 of 61 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181403: Innova IGS 5, Innova IGS 6, Discovery IGS 7, Discovery IGS 7 OR, GE Healthcare (2018) Summary page 5.

## Indications for use
3DXR is the AW application which is intended to perform the three-dimensional (3D) reconstruction computation of any images acquired with a 3D Acquisition mode of the X-ray interventional system for visualization under Volume Viewer. The 3D Acquisition modes are intended for imaging vessels, bones and soft tissues as well as other internal body structures. The 3D reconstructed Volume assist the physician in diagnosis, surgical planning, Interventional procedures and treatment follow-up.

Source page: https://510kreport.com/device/K243446
Methodology: https://510kreport.com/methodology