CINA

Organization name

Avicenna.AI

SRN

FR-MF-000000324

Manufacturer status

Active

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• CW010

  EUDAMED did not publish a description for this code.

Primary placement in France; available across 32 countries total.

Trade name

CINA

UDI-DI code

+B826CINA100

Basic UDI-DI

++B826CINA10RR

Reference / catalog number

CINA

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 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 suspicious results of an intracranial hemorrhage (ICH) or a large vessel occlusion (LVO), 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 patient name, accession number and the type of suspected findings (ICH or LVO). All the non-enhanced head CT images and head CT angiography studies received by Cina device are displayed in the worklist and those on which the algorithms have detected a suspected finding (ICH or LVO) 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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