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510(k) Data Aggregation
K Number
K033577Device Name
UNISCAN, PULMOSCAN, PULMOSCAN RADIOGRAPHIC SYSTEMS
Manufacturer
MEDLINK IMAGING
Date Cleared
2005-03-18
(491 days)
Product Code
KPR
Regulation Number
892.1680Why did this record match?
Applicant Name (Manufacturer) :
MEDLINK IMAGING
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended 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 early diagnostics of the thorax organs.
- The DRS system of the "Pulmoscan-T" model is a mobile specialized-purpose diagnostic system, particularly, for mass examination (screening) of wide groups of population directly at the places of their maximum concentration (in educational institutions and at enterprises), in remote areas (villages, military units), in institutions with the special access regime (refugees camps, penal jurisdiction) with the purpose of early diagnostics of the thorax organs.
Device Description
The principal of functioning of the DRS system is based on:
- generation of highly stable low-energy X-ray radiation (from 40 up to 150 keV) with controllable parameters (voltage, current, time, exposure duration) by means of an X-ray source connected to the X-ray power supply unit;
- formation of a flat narrow with the width D fan-shaped X-ray beam with the possibility of masking according to the radiation angle a by means of the adjustable diaphragm;
- adjustment of the area of the patient's body to be examined (input dimensions A B) by scanning with a flat X-ray beam in the field of the scanning angle b with the possibility of specifying and visual control of the scanning (exposure) field;
- magnification of the planar X-ray image of the patient with the specified enlargement by projecting it to the scanning X-ray detector located at a considerable distance from the patient;
- obtaining the digital X-ray image of the area to be examined by means of the scanning X-ray detector (on the basis of a linear matrix multiclement semiconductor detector), converting the absorbed X-ray radiation into digital form;
- formation of the two-dimensional digital projection image on the computer monitor with the possibility of manipulation and archiving by means of the special software
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