# K033577: Uniscan, Pulmoscan, Pulmoscan Radiographic Systems

- Pathway: 510(k) (Abbreviated)
- Applicant: Medlink Imaging
- Decided: Mar 18, 2005 after 491 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: 3 generations back to K803130 (1981). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983732: Thorax FD and Multix FD, Siemens Medical Solutions USA, Inc. (1999) Summary page 1.

## Indications for use
The DRS system of the “Uniscan” model is a stationary general-purpose diagnostic (universal) system for obtaining standard planar X-ray images of the bone structure and soft tissues of a patient in the standing, sitting and lying position The DRS system of the “Pulmoscan” model is a stationary specialized-purpose diagnostic system for mass examination (screening) of wide groups of population, first of all, in polyclinics at the stage of before-doctor examination with the purpose of carly diagnostics of the thorax organs. The DRS system of the “pulmoscan-T" model is a mobile specialized-purposc diagnostic system, particularly, for mass examination (screening) of widc groups of population directly at the places of their maximum concentration (in educational institutions and at enterprises), in remote arcas (villages, military units), in institutions with the special access regime (refugees camps, penal jurisdiction) with the purposc of early diagnostics of the thorax organs.

Source page: https://510kreport.com/device/K033577
Methodology: https://510kreport.com/methodology