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…

Registry build 21.09.26

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.

1manufacturer
1catalogue number
5510(k) clearances naming this product code

Who Else Makes It

Registered in Beijing.

Chinese manufacturers registered for FDA product code QAS
Manufacturer City Province Registered as Device types
Beijing Infervision Healthcare Medical Technology Co., Ltd. Beijing Beijing Complaint-file establishment 4

Record

Regulatory record for Cina Chest
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

Specifications
MRI safety Labeling does not contain MRI Safety Information
Prescription Prescription only
Label carries lot or batch number, serial number

Catalogue Numbers

Catalogue numbers for Cina Chest
Catalogue number Size Status
1.0 In distribution

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Showing 12 of 29. All products under Radiological Computer-Assisted Triage And Notification Software

510(K) Clearances

FDA 510(k) clearances naming this product code
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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer