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Cina-Vcf

FDA UDI

Class II (US FDA UDI)

by Avicenna.ai

Identity

Trade Name
CINA-VCF FDA UDI
Generic Name
Radiology DICOM image processing application software FDA UDI
Device Name
CINA-VCF is a radiological computer aided triage and notification software indicated for use in patients aged 50 years and over undergoing non-enhanced or contrast-enhanced CT scans which include the chest and/or abdomen. The device is intended to assist hospital networks and appropriately trained medical specialists within the standard-of-care bone health setting in workflow triage by flagging and communication of suspected positive cases of Vertebral Compression Fractures (VCF) findings. CINA-VCF uses an artificial intelligence algorithm to analyze images and highlight cases with detected findings 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. This document is the property of Avicenna.AI and cannot be reproduced without written authorisation. The results of CINA-VCF are intended to be used in conjunction with other patient information and based on professional judgment to assist with triage/prioritization of medical images. Notified clinicians are ultimately responsible for reviewing full images per the standard of care. FDA UDI
Model / Reference
1.0 FDA UDI
Description
CINA-VCF is a radiological computer aided triage and notification software indicated for use in patients aged 50 years and over undergoing non-enhanced or contrast-enhanced CT scans which include the chest and/or abdomen. The device is intended to assist hospital networks and appropriately trained medical specialists within the standard-of-care bone health setting in workflow triage by flagging and communication of suspected positive cases of Vertebral Compression Fractures (VCF) findings. CINA-VCF uses an artificial intelligence algorithm to analyze images and highlight cases with detected findings 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. This document is the property of Avicenna.AI and cannot be reproduced without written authorisation. The results of CINA-VCF are intended to be used in conjunction with other patient information and based on professional judgment to assist with triage/prioritization of medical images. Notified clinicians are ultimately responsible for reviewing full images per the standard of care. FDA UDI

Identifiers

Primary DI / UDI-DI
B826CINAVCF100 FDA UDI
510(k) Number
K240612 FDA UDI
FDA Product Code
QFM FDA UDI
GMDN Term
Radiology DICOM image processing application software FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.2080 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Radiology DICOM image processing application software

Cina-Vcf by Avicenna.ai — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Radiology DICOM image processing application software.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Avicenna.ai

Sources (1)

  • FDA UDI b9606c62-4b4b-43b0-8339-09f557feb245 34 fields · synced Jun 1, 2026