LUCIA Cytogenetics

Primary DI

08594211580014

Basic UDI-DI Code

859421158LCGQC

Reference

N/A

Device Types

None provided

Regulation

Eu Ivdr

Classification

Eu Ivd Class C

Status

On The Market

Manufacturer

Laboratory Imaging s.r.o.

LUCIA Cytogenetics is in vitro diagnostic medical device software that helps the user to perform the chromosome analysis (digital karyotyping and FISH) by means of digital image manipulation and analysis. The device takes a digital image as the input data and helps a laboratory professional namely, a qualified cytogeneticist, bioanalyst, pathologist, medical scientist or cytogenetic technician to achieve diagnostic or analytical results in the diagnosis of chromosomal disorders or risk factors. The software provides user tools that are manual, semi-automatic or automatic; some tools provide qualitative as well as quantitative information. Namely the device assists the users to count chromosomes or cells, to arrange karyograms, to evaluate structure of chromosomes or to evaluate spatial location of fluorescent signals. LUCIA Cytogenetics allows the user of the device to draw a conclusion and provide it as a result to a medical professional. The software does not provide any diagnostic or treatment recommendation nor has any direct physical impact on a patient. LUCIA Cytogenetics is intended to be used on the input images acquired using bright field or fluorescence microscopy that show cell chromosomes or cells stained with fluorescent dyes binding to chromosomal DNA.

Other on-the-market devices with the same classification (Eu Ivd Class C) and regulation (EU IVDR).