# K210237: Cina Chest

- Pathway: 510(k) (Traditional)
- Applicant: Avicenna.Ai
- Decided: May 19, 2021 after 111 days
- Product code: QAS (Radiological Computer-Assisted Triage And Notification Software)
- 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: 3 generations back to DEN170073 (2018). 3 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190072: BriefCase, Aidoc Medical, Ltd. (2019) Summary page 4.

## Most influential descendants
- K222329: BriefCase (2022), 4 descendants of its own
- K251406: BriefCase-Triage (2025), 2 descendants of its own
- K253578: BriefCase-Triage: CARE Multi-Triage CT for Pneumothorax; Pericardial effusion; Large aortic aneurysm; Shoulder fracture or dislocation device (2026), 0 descendants of its own
- K252970: BriefCase-Triage: CARE Multi-triage CT Body (2026), 0 descendants of its own
- K240291: Efai Cardiosuite Cta Acute Aortic Syndrome Assessment System (2024), 0 descendants of its own

## Indications for use
CINA CHEST is a radiological computer aided triage and notification software indicated for use in the analysis of Chest and Thoraco-abdominal CT angiography. The device is intended to assist hospital networks and trained radiologists in workflow triage by flagging and communicating suspected positive findings of (1) Chest CT angiography for Pulmonary Embolism (PE) and (2) Chest or Thoraco-abdominal CT angiography for Aortic Dissection (AD). CINA CHEST uses an artificial intelligence algorithm to analyze images and highlight cases with detected PE and AD on a standalone Web application in parallel to the ongoing standard of care image interpretation. The user is presented with notifications for cases with suspected PE or AD findings. Notifications include compressed preview images that are meant for informational purposes only, and are not intended for diagnostic use beyond notification. 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 CHEST 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/K210237
Methodology: https://510kreport.com/methodology