CINA-CSpine

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-CSpine

UDI-DI code

+B826CINACSPINE100

Basic UDI-DI

++B826CINACSPINE10T5

Reference / catalog number

CINA-CSpine

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-CSpine is a radiological, computer-assisted triage and notification software. It runs on standard off-the-shelf servers or workstations and includes the CSpine Image Processing Application. This application can be used with the CINA Platform (FDA cleared under K200855) or other medical imaging communication systems. CINA-CSpine processes cervical spine CT scans identified by the CINA Platform or similar devices. It uses a deep learning model trained end-to-end on 1,338 cases from the US and France, covering a broad range of fracture types, anatomical locations, scanner models (Siemens, Philips, GE, Canon/Toshiba), and acquisition protocols. Additional AI models identify vertebrae and exclude images outside the expected field of view. The system receives, records, and filters DICOM images before analyzing them. Each CT series is processed chronologically using algorithms that detect suspected acute cervical spine fractures. When a potential finding is identified, an active notification is sent to the worklist system. The Worklist Application highlights studies with suspected findings using an icon and displays a compressed, grayscale preview image labeled “not for diagnostic use.” This preview serves informational purposes only and contains no annotations. CINA-CSpine displays all cervical CT studies with at least five visible vertebrae and prioritizes those flagged by the algorithm. This early notification system enables radiologists to triage cases faster, helping ensure that potential fractures are reviewed sooner than in traditional workflows.

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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