# K202394: EOSedge

- Pathway: 510(k) (Special)
- Applicant: Eos Imaging
- Decided: Sep 16, 2020 after 26 days
- Product code: KPR (System, X-Ray, Stationary)
- Device class: 2
- Regulation: 21 CFR 892.1680
- 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: 9 generations back to K803130 (1981). 20 ancestors in all.
1 later device descends 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)
- K192079: EOSedge, Eos Imaging (2019) Summary page 4.

## Most influential descendants
- K233920: EOSedge (2024), 0 descendants of its own

## Recalls of this device
- Dec 22, 2020 · Class II · Z-1415-2021: Inadequate images resizing and 2D measurement errors may occur when biplanar acquisition has been performed with patient orientation different from AP (Antero-Posterior).

## Indications for use
EOSedge is intended for use in general radiographic exams and applications, excluding the evaluation of lung nodules and exams involving fluoroscopy, angiography, and mammography. EOSedge 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 assessing global skeletal deformities in follow-up pediatric exams.

Source page: https://510kreport.com/device/K202394
Methodology: https://510kreport.com/methodology