# K123740: EOS

- Pathway: 510(k) (Special)
- Applicant: Eos Imaging
- Decided: Feb 22, 2013 after 79 days
- Product code: MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager))
- 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: 5 generations back to K803130 (1981). 16 ancestors in all.
5 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)
- K120721: EOS, Eos Imaging (2012) Summary page 1.
- K071546: EOS, Biospace Med (2007) Summary page 1.

## Most influential descendants
- K142773: EOS System (2015), 4 descendants of its own
- 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

## Recalls of this device
- Feb 17, 2015 · Class II · Z-1460-2015: When performing calibration, an alert message on the spectral filtration of the X-ray beam may be suppressed. Improper filtration of the X-ray Beam can then occur in exams set up with copper filtratio

## Indications for use
The FOS 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.

Source page: https://510kreport.com/device/K123740
Methodology: https://510kreport.com/methodology