CINA-CHEST

Organization name

Avicenna.AI

SRN

FR-MF-000000324

Manufacturer status

Active

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• CW010

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Primary placement in France; available across 32 countries total.

Trade name

CINA-CHEST

UDI-DI code

+B826CINACHEST100

Basic UDI-DI

++B826CINACHEST10VN

Reference / catalog number

CINA-CHEST

Issuing entity

HIBCC

Risk category

Class IIb

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

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.

Additional information URL

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

Clinical sizes

No clinical sizes registered for this device.

• Z11039092VARIOUS RADIODIAGNOSTIC AND INTERVENTIONAL INSTRUMENTS - MEDICAL DEVICE SOFTWARE

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