# K142773: EOS System

- Pathway: 510(k) (Traditional)
- Applicant: Eos Imaging
- Decided: Jan 22, 2015 after 119 days
- Product code: KPR (System, X-Ray, Stationary)
- Device class: 2
- Regulation: 21 CFR 892.1680
- 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 K803130 (1981). 17 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123740: EOS, Eos Imaging (2013) Summary page 4.

## Most influential descendants
- K152788: EOS System (2015), 3 descendants of its own
- K192079: EOSedge (2019), 2 descendants of its own
- K202394: EOSedge (2020), 1 descendant of its own
- K233920: EOSedge (2024), 0 descendants of its own

## Indications for use
EOS is intended for use in general radiographic examinations and applications, excluding the evaluation of lung nodules and examinations involving fluoroscopy, angiography, and mammography. EOS allows the radiographic acquisition of either one or two orthogonal X-ray images for diagnostic purposes, in one single scan, of the whole body or a reduced area of investigation of a patient in the upright or seated position. The Micro Dose feature is indicated for imaging with a patient entrance dose of 10 to 90 μGy for assessing global skeletal deformities in follow-up pediatric examinations. Micro Dose is not indicated for focal skeletal abnormalities and/or other pediatric abnormalities. Micro Dose is not indicated for use in patients with a Body Mass Index over 30.

Source page: https://510kreport.com/device/K142773
Methodology: https://510kreport.com/methodology