CS-BreastCancer HER2

Organization name

CELLS IA TECHNOLOGIES S.L.

SRN

ES-MF-000042517

Manufacturer status

Active

Primary placement in Spain; available across 1 country total.

Placed on the market in Spain; per-country availability dates not published.

Trade name

CS-BreastCancer HER2

UDI-DI code

08437027144127

Basic UDI-DI

B-08437027144127

Reference / catalog number

CS-BreastCancer HER2 V0.0.0

Issuing entity

GS1

Risk category

IVDD — General

Applicable legislation

IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]

Status

On the market

Quantity

1

Additional product description

The CS-BreastCancer HER2 algorithm is intended for cancer screening in breast tissue samples: - Detects cells positive for the HER2 antibody. - Assists in the diagnosis of pathological conditions by identifying the presence of the HER2 antibody. - Provides specific information on a physiological or pathological state. - Automated quantitative algorithm that integrates Artificial Intelligence. - Uses breast tissue samples from patients of any gender and age. Therefore, the purpose of the algorithm is to provide the pathologist or healthcare professional using it with an automatic identification of findings, facilitating the reading of areas with the presence of cells positive for the HER2 antibody on an image of a processed breast tissue sample. This is done by highlighting possible areas of interest so that the pathologist can make a faster and safer diagnosis, less influenced by individual variability between observers, since the process is standardized. The diagnosis provided by the algorithm is not definitive: it must always be validated by the pathologist, who confirms the accuracy of the generated information.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• W02069092VARIOUS SAMPLE PROCESSING INSTRUMENTS - IVD MEDICAL DEVICE SOFTWARE

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