CINA-VCF Quantix

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-VCF Quantix

UDI-DI code

+B826CINAVCFQUANTIX100

Basic UDI-DI

++B826CINAVCFQUANTIX10NR

Reference / catalog number

CINA-VCF Quantix

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-VCF Quantix is an automated image processing and analysis tool indicated to assist hospital networks and trained medical specialists involved in the bone health care of patients aged 50 years and over undergoing non-enhanced or contrast-enhanced CT scans, for any clinical indication, which include the chest and/or abdomen. It is intended for the automatic labeling, vertebral height loss ratio calculation, and mean Hounsfield Unit measurements of thoracic and/or lumbar spine vertebrae and provides the user with annotated images showing this information. A passive notification is sent to the user if the vertebral height loss ratio is above a pre-established threshold (20% or 25%) which is compatible with a potential Vertebral Compression Fracture. CINA-VCF Quantix uses an artificial intelligence algorithm to analyze images and highlight cases with significant vertebral height loss on a standalone application in parallel to the ongoing standard of care image interpretation. The device does not alter the original medical image, and it is not intended to be used as a diagnostic device. The results of CINA-VCF Quantix are intended to be used in conjunction with other patient information and based on professional judgment. Notified clinicians are ultimately responsible for reviewing full images per the standard of care.

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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