CINA CHEST
K210237Avicenna.AI · cleared 2021-05-19 · product code QAS · Radiology
Premarket evidence — what FDA accepted
source quote (p.3)
“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).”
source quote (p.5)
“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. software packages with similar technological characteristics and principles of operation, and incorporate deep learning Al algorithms that process images, and software to send notifications and to display unannotated preview images.”
Validation studies (1)
Retrospective clinical
n=694 cases
endpoints: software's performance in Chest CT angiography (CTA) images pertaining to patient with suspected Pulmonary Embolism (PE) findings; software's performance in Chest or Thoraco-abdominal CT angiography (CTA) images series pertaining to patient with suspected Aortic Dissection (AD) findings; Sensitivity; Specificity; Overall Agreement (Accuracy); Matthews correlation coefficient (MCC); Time-to-Notification
Reported performance (6 observations)
source quote (p.7)
“Sensitivity and Specificity for the “PE” prioritization and triage application were found to be 91.1% [95% CI: 86.1% – 94.7%] and 91.8% [95% CI: 87.1% – 95.1%], respectively.”
source quote (p.7)
“Sensitivity and Specificity for the “PE” prioritization and triage application were found to be 91.1% [95% CI: 86.1% – 94.7%] and 91.8% [95% CI: 87.1% – 95.1%], respectively.”
source quote (p.7)
“Regarding the "AD” prioritization and triage application, Sensitivity and Specificity of 96.4% [95% CI: 91.7% – 98.8%] and 97.5% [95% CI: 93.8% – 99.3%], respectively, were obtained.”
source quote (p.7)
“Regarding the "AD” prioritization and triage application, Sensitivity and Specificity of 96.4% [95% CI: 91.7% – 98.8%] and 97.5% [95% CI: 93.8% – 99.3%], respectively, were obtained.”
source quote (p.8)
“Specifically, mean “time-to-notification” were estimated to be 63 [95% CI: 61.5 – 64.6] seconds and 36.5 [95% CI: 35.4 – 37.5] seconds for CINA CHEST – PE and CINA CHEST – AD, respectively.”
source quote (p.8)
“Specifically, mean “time-to-notification” were estimated to be 63 [95% CI: 61.5 – 64.6] seconds and 36.5 [95% CI: 35.4 – 37.5] seconds for CINA CHEST – PE and CINA CHEST – AD, respectively.”
Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.
Predicate network
Postmarket — what happened after clearance
- re_clearance
The FDA AI/ML device list shows a newer 510(k) K221716 (decision 2022-11-22) from AVICENNA.AI for a matching device line ("CINA") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K221716
Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device). Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.
Reimbursement — how devices like this got paid
Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).