CINA CHEST
Avicenna.AICINA CHEST is an AI-powered software that analyzes chest and thoraco-abdominal CT angiography scans to detect signs of pulmonary embolism and aortic dissection. It helps radiologists prioritize cases by flagging suspected positive findings through notifications, thereby improving workflow efficiency and timely patient care. The tool works alongside standard image interpretation without altering original images and is not intended for diagnosis alone but as an aid for faster triage.
Intended 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 to assist hospital networks and trained radiologists by flagging suspected positive findings of Pulmonary Embolism and Aortic Dissection.
Technology
CINA CHEST operates on a standard off-the-shelf workstation and includes PE and AD image processing applications that analyze DICOM CT angiography images using AI algorithms to detect suspected PE or AD. It communicates findings via notifications and displays small compressed preview images for informational purposes, integrating with hospital PACS and workflow systems.
Performance
The device was evaluated in a multicenter blinded clinical study on 396 PE and 298 AD cases, showing high sensitivity (PE: 91.1%, AD: 96.4%) and specificity (PE: 91.8%, AD: 97.5%) compared to radiologist ground truth. Time-to-notification was approximately 63 seconds for PE and 36.5 seconds for AD, meeting performance goals and demonstrating substantial equivalence to predicate devices.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
1/28/2021
3 months - 2
FDA Approval
5/19/2021
Other devices from Avicenna.AI
- CINA-CSpine2024 • 510K
- CINA-VCF2024 • 510K
- CINA-ASPECTS2024 • 510K
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