Cina Chest
CINA CHEST is radiological triage and notification software for chest or thoraco-abdominal CT angiography. It analyzes images for pulmonary embolism and aortic dissection and presents…
CINA CHEST is radiological triage and notification software for chest or thoraco-abdominal CT angiography. It analyzes images for pulmonary embolism and aortic dissection and presents notifications for cases with suspected findings through a standalone web application.
The filing describes an AI algorithm that processes CTA images alongside standard image interpretation. Notifications include compressed preview images for informational purposes, while clinicians review the full images under standard care. The output supports image prioritization and is used with other patient information and professional judgment.
Listed Item
CINA CHEST is a radiological computer aided triage and notification software indicated for use in the analysis of Chest and Thoraco-abdominal CT angiographies. 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 angiographies for Pulmonary Embolism (PE) and (2) Chest or Thoraco-abdominal CT angiographies 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.
Triage Workflow
CINA CHEST can run with a compatible image communications device and receives CTA scans for algorithmic processing. It highlights suspected findings to aid prioritization; clinicians review the full images.
Who Else Makes It
Registered in Beijing.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Beijing Infervision Healthcare Medical Technology Co., Ltd. | Beijing | Beijing | Complaint-file establishment | 4 |
Record
| Listed by | Avicenna.ai, France |
|---|---|
| FDA product code | QAS |
| Device type | Radiological Computer-Assisted Triage And Notification Software |
| Device class | Class 2 |
| Regulation | 21 CFR 892.2080 |
| Establishment | Complaint-file establishment, Manufacturer |
| 510(k) | K210237 |
| Record published | 2021-06-02 |
| Record revised | 2023-12-04 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1.0 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Viz LVO | Viz.ai, Inc. | 12 |
| Triage Stroke | Brainomix Limited | 5 |
| BriefCase Triage | Aidoc Medical Ltd. | 5 |
| Triage LVO | Brainomix Limited | 5 |
| BriefCase | Aidoc Medical Ltd. | 3 |
| HealthICH | Nano-X AI Ltd. | 3 |
| Annalise Triage | Harrison-AI Medical Pty Ltd | 3 |
| Triage ICH | Brainomix Limited | 3 |
| syngo.CT Brain Hemorrhage | Siemens Healthcare Limited | 2 |
| AccipioIx | Maxq AI Ltd | 2 |
| Viz ICH | Viz.ai, Inc. | 2 |
| qER | Qure.ai Technologies Private Limited | 1 |
Showing 12 of 29. All products under Radiological Computer-Assisted Triage And Notification Software
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K240942 | 2024-09-12 |
| K233968 | 2024-03-13 |
| K221716 | 2022-11-22 |
| K210237 | 2021-05-19 |
| K200855 | 2020-06-24 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.