clinalytix Medical A

Organization name

DH Healthcare GmbH

SRN

DE-MF-000009069

Manufacturer status

Active

Primary placement in Germany; available across 2 countries total.

Trade name

not provided

UDI-DI code

04260693990101

Basic UDI-DI

426069399CLINALYTIXH4

Reference / catalog number

clinalytix Medical A

Issuing entity

GS1

Risk category

Class IIa

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

clinalytix Medical AI consists of clinical prediction services, each estimating, for a given patient, the risk of one type of clinical event. The predictions may assist the treating physician as an additional source for risk estimation, and are intended to complement, i.e. enhance rather than replace, established detection methods or practices. Currently, the services predict the risk of occurrence of: • an episode of delirium during the hospitalization; • an episode of sepsis during the hospitalization; • an episode of acute kidney injury during the hospitalization. clinalytix Medical AI does not provide stand-alone prediction services: each service is intended to be integrated into (third-party) HIS applications. The inpatient’s treating physician use the result of the prediction services in combination with established risk estimation and detection methods and practices, to estimate the patient’s risk of developing the condition that is specific for each service.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• Z120499GENERAL MEDICINE INSTRUMENTS - OTHER

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