# K240612: Cina-VCF

- Pathway: 510(k) (Traditional)
- Applicant: Avicenna.Ai
- Decided: May 31, 2024 after 87 days
- Product code: QFM (Radiological Computer-Assisted Prioritization Software For Lesions)
- Device class: 2
- Regulation: 21 CFR 892.2080
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to DEN170073 (2018). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222692: BriefCase, Aidoc Medical, Ltd. (2022) Summary page 4.

## Indications for use
CINA-VCEF 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. 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.

Source page: https://510kreport.com/device/K240612
Methodology: https://510kreport.com/methodology