# K080614: DR Vision Neo, DR Vision Dou

- Pathway: 510(k) (Traditional)
- Applicant: Almana Medical Imaging
- Decided: Jun 20, 2008 after 107 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: 7 generations back to K801623 (1980). 42 ancestors in all.
No later device cites it as a predicate yet.
0 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061054: Axiom Aristos FX Plus, Siemens Medical Solutions USA, Inc. (2006) Summary page 1.

## Indications for use
These are Radiographic X-Ray Systems with a flat panel detector(s), which allow the acquisition of x-ray exposures without the use of conventional film/screen systems. The systems allow radiographic exposures of the whole body including skull, spinal column, chest, abdomen, extremities, excluding mammography. Radiographic exposures may be taken with the patient in the sitting, standing, or lying positions.

Source page: https://510kreport.com/device/K080614
Methodology: https://510kreport.com/methodology