Aorta-CAD

K213353

Imagen Technologies, Inc · cleared 2022-09-20 · product code MYN · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.3)
“Aorta-CAD is a computer-assisted detection (CADe) software device that analyzes chest radiograph studies for suspicious regions of interest (ROIs). The device uses a deep learning algorithm to identify ROIs and produces boxes around the ROIs. The subject device is a software-only device.”
Algorithmdeep learning algorithm
source quote (p.3)
“The device uses a deep learning algorithm to identify ROIs and produces boxes around the ROIs. Aorta-CAD uses modern deep learning and computer vision techniques to analyze chest radiographs.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this

Validation studies (2)

Bench

n=5,000 cases

endpoints: sensitivity; specificity; AUC; FROC curve

Reader study (MRMC)

n=244 cases

endpoints: Reader AUC improvement (Aided vs Unaided)

Reported performance (7 observations)

sensitivity0.91CI 0.896, 0.922
source quote (p.8)
“The results of the standalone testing demonstrated that Aorta-CAD detects ROIs with high sensitivity (0.910; 95% Wilson's Confidence Interval: 0.896, 0.922)”
specificity0.896CI 0.889, 0.902
source quote (p.8)
“high specificity (0.896; 95% Wilson's Confidence Interval: 0.889, 0.902)”
aurocas written: “auc”0.974CI 0.971, 0.977
source quote (p.8)
“high Area Under the Curve (AUC) of the Receiver Operating Characteristic (ROC) curve (0.974, 95% Bootstrap Confidence Interval: 0.971, 0.977).”
ppvas written: “Positive Predictive Value (Aortic calcification)”0.812CI 0.794, 0.829
source quote (p.10)
“0.812 (0.794, 0.829)”
npvas written: “Negative Predictive Value (Aortic calcification)”0.958CI 0.951, 0.965
source quote (p.10)
“0.958 (0.951, 0.965)”
ppvas written: “Positive Predictive Value (Dilated aorta)”0.296CI 0.263, 0.331
source quote (p.10)
“0.296 (0.263, 0.331)”
npvas written: “Negative Predictive Value (Dilated aorta)”0.99CI 0.987, 0.993
source quote (p.10)
“0.990 (0.987, 0.993)”

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

0
recalls in product code, 24mo
0
MAUDE reports in code, 12mo
-100%
vs code's own 3-yr baseline
0
drift signals on this device

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device); a recall is shown as device-attributed only when the recall record itself lists this clearance number. 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).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Radiology panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K213353