CS-Caprost

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-Caprost

UDI-DI code

08437027144066

Basic UDI-DI

B-08437027144066

Reference / catalog number

CS-Caprost 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-CAPROST algorithm is intended for cancer screening in prostate tissue samples: • Detects malignant prostate tissue. • Helps in the diagnosis of cancer. • It provides specific information about a physiological or pathological state. • Qualitative automated algorithm that integrates Artificial Intelligence (AI). • It uses prostate tissue samples from patients assigned male at birth of any age. Therefore, the purpose of the algorithm is to provide the pathologist or health professional who uses it, an automatic identification of the findings, facilitating the reading of the areas with the presence of cancer, on an image of a processed sample of prostate tissue. This is done by showing the possible areas of interest, so that the pathologist can make a faster and safer diagnosis, less influenced by individual variability between observers as it is standardized. The diagnosis provided by the algorithm is not definitive: it must always be validated by the pathologist, who must check the veracity and accuracy of the information generated by the algorithm.

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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