SBAS Software

Nom de l'organisation

Smart Blood Analytics Swiss SA

SRN

CH-MF-000024251

Statut du fabricant

Actif

1 avertissement enregistré — faire défiler le panneau pour tout voir.

• CW010

  1. The final patient diagnosis shall always be determined by the responsible physician based on all available physical findings, patients’ anamneses, symptoms and results of other diag-nostic tests. The information provided by the software is intended to support the determi-nation of the diagnosis. 2. The use of SBAS Software is not allowed without consideration for the symptoms of a patient and their medical history. The SBAS Software should also not be used for screening purposes. 3. The SBAS Software can only be used if biological sex, age and a minimum of 30 blood test parameters from the List of blood parameters are available 4. The SBAS Software can only predict the disease that is available in its database. All the available diseases are listed in the List of diseases available in Annex 2. 5. The SBAS Software is not designed to be used on healthy patients. The use on healthy patients will provide non-relevant information.

Marché principal en Slovénie ; disponible dans 32 pays au total.

Dénomination commerciale

non renseigné

Code d'UDI-DI

07649996089335

Basic UDI-DI

7649996089SBASRC

Numéro de référence/catalogue

SBAS Software

Entité d'attribution

GS1

Catégorie de risque

Classe IIa

Législation applicable

MDR [Règlement (UE) 2017/745 relatif aux dispositifs médicaux]

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

All by itself the SBAS Software is a standalone/ independent medical device, intended to provide information to physicians concerning medical conditions or diseases, based on the patient’s set of data. Data contains biological sex, age and results of blood tests, which have been performed in an external medical laboratory independent from SBAS Software. The software provides a ranking of potential diseases to be used by physicians performing advanced differential diagnosis. It operates by using machine-learning algorithms trained on clinical cases.

URL des informations complémentaires

Aucune URL d'informations complémentaires renseignée par le fabricant.

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

• V92MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES

• Numéro de lot
• Date d'expiration
• Date de fabrication
• Numéro de série
• Identification du logiciel

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