# K071546: EOS

- Pathway: 510(k) (Traditional)
- Applicant: Biospace Med
- Decided: Sep 18, 2007 after 104 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: 3 generations back to K803130 (1981). 14 ancestors in all.
7 later devices descend from it; 2 cite 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)
- K013999: Lodox, Model Baseline, Lodox Systems (Pty), Ltd. (2002) Summary page 1.
- K973908: Auklet CT Scanner, TSX-003A, Toshiba America Medical Systems, In.C (1997) Summary page 1.
- K790692: Televix, General Electrical Espanola, S.A. (1979) Summary page 1.
- K945278: Philips Bucky Diagnost Family, Philips Medical Systems North America, Inc. (1994) Summary page 1.
- K843926: Prestilix 1690, Cgr Medical Corp. (1984) Summary page 1.
- K020635: Kodak Directview CR 800 System, Catalog# 1268622; Kodak Directview CR 900 System, Catalog# 1170976, Eastman Kodak Company (2002) Summary page 1.
- K983732: Thorax FD and Multix FD, Siemens Medical Solutions USA, Inc. (1999) Summary page 1.

## Most influential descendants
- 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
- K192079: EOSedge (2019), 2 descendants of its own

## Recalls of this device
- Apr 13, 2011 · Not classified · Z-2692-2011: Print true size, print requests from the EOS acquisition station or the sterEOS image review station may, in certain cases, be affected by a different enlargement factor during printing. T

## Indications for use
The 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.

Source page: https://510kreport.com/device/K071546
Methodology: https://510kreport.com/methodology