# K013999: Lodox, Model Baseline

- Pathway: 510(k) (Traditional)
- Applicant: Lodox Systems (Pty), Ltd.
- Decided: Aug 6, 2002 after 245 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: 1 generation back to K884671 (1989). 2 ancestors in all.
8 later devices descend from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K884671: Exel 2400 and 2400 Elite CT Scanners, Elscint, Inc. (1989) Summary page 2.
- K950883: Polydoros SX 65 and 80, Siemens Medical Solutions USA, Inc. (1995) Summary page 2.
- (no number) bucky (x-ray film holder) using conventional radiographic film: named in the summary without a submission number

## Most influential descendants
- K071546: EOS (2007), 7 descendants of its own
- K120721: EOS (2012), 6 descendants of its own
- K123740: EOS (2013), 5 descendants of its own
- K142773: EOS System (2015), 4 descendants of its own
- K152788: EOS System (2015), 3 descendants of its own

## Indications for use
The Lodox whole-body x-ray scanner is mainly intended for use in trauma wards where multiple injuries can be medically diagnosed in a very short time. It can also be used for normal x-ray examinations as is currently practised with general-purpose single-shot x-ray machines. A full image area is 1800 mm by 680 mrn, and can be reduced to any size down to 100 mm by 100 mm anywhere within the image area.

Source page: https://510kreport.com/device/K013999
Methodology: https://510kreport.com/methodology