CS-PHH3

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-PHH3

UDI-DI code

08437027144035

Basic UDI-DI

B-08437027144035

Reference / catalog number

CS-PHH3 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-PHH3 algorithm is intended for screening pathological conditions in stomach tissue samples: - Detects the presence of mitotic cells in malignant tumors. - Assists in diagnosing pathological conditions related to the presence of mitotic cells in malignant tumors. - Provides specific information about a physiological or pathological state. - A quantitative automated algorithm that integrates Artificial Intelligence. - Uses tumor 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 interpretation of areas with mitotic cells on an image of a processed biopsy of tumor tissue. This is achieved by highlighting potential areas of interest so that the pathologist can make a faster and safer diagnosis, less influenced by inter-observer variability since it 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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