CINA-CHEST

Dénomination commerciale

CINA-CHEST

Code d'IUD-ID

+B826CINACHEST100

IUD-ID de base

++B826CINACHEST10VN

Numéro de référence/catalogue

CINA-CHEST

Entité d'attribution

HIBCC

Catégorie de risque

Classe IIb

Législation applicable

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

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

CINA-CHEST is a radiological computer-assisted triage and notification software device. The software system is based on algorithm-programmed components and is comprised of a standard off-the-shelf operating system and additional image-processing applications. DICOM images are received, recorded, and filtered before processing. The series are processed chronologically by running algorithms on each series to detect suspected positive findings of a pulmonary embolism (PE) or an aortic dissection (AD), and then notifications on the flagged series are sent to the Worklist Application. The Worklist Application (on-premise) displays the pop-up notifications of new studies with suspected findings when they come in and provides both active and passive notifications. Active notifications are in the form of a small pop-up containing the patient name, accession number, and the type of suspected findings (PE or AD). All the chest and thoraco-abdominal CT angiography studies received by CINA-CHEST device are displayed in the worklist and those on which the algorithms have detected a suspected finding (PE or AD) are marked with an icon (i.e., passive notification). In addition, a compressed, small black-and-white image that is marked “not for diagnostic use” is displayed as a preview function. This compressed preview is meant for informational purposes only, does not contain any marking of the findings, and is not intended for primary diagnosis beyond notification. Presenting the radiologist with notification facilitates earlier triage by allowing one to prioritize images in the PACS. Thus, the suspect case receives attention earlier than would have been the case in the standard of care practice alone.

URL des informations complémentaires

https://my.avicenna.ai/portal/en/signin

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

Nomenclature européenne des dispositifs médicaux — la classification produit UE attribuée à ce dispositif.

• Z11039092VARIOUS RADIODIAGNOSTIC AND INTERVENTIONAL INSTRUMENTS - MEDICAL DEVICE SOFTWARE

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

• CW010

  EUDAMED n'a pas publié de description pour ce code.

Aucun certificat ne référence l'IUD-ID de base de ce dispositif.