Lung-CAD

K223811

Imagen Technologies, Inc · cleared 2023-09-13 · product code MYN · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.3)
“Lung-CAD is a computer-assisted detection (CADe) software device that analyzes chest radiograph studies for interstitial thickening.”
Algorithmdeep learning, computer vision
source quote (p.5)
“Lung-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 addressedYes
source quote (p.7)
“HIPAA Compliant”

Validation studies (2)

Bench

n=5,000 cases

endpoints: sensitivity; specificity; AUC

Reader study (MRMC)

n=244 cases

endpoints: reader AUC improvement

Reported performance (6 observations)

sensitivity0.913CI 0.850, 0.951
source quote (p.8)
“high sensitivity (0.913; 95% Wilson's Confidence Interval: 0.850, 0.951)”
specificity0.866CI 0.856, 0.875
source quote (p.8)
“high specificity (0.866; 95% Wilson's Confidence Interval: 0.856, 0.875)”
aurocas written: “auc”0.961CI 0.948, 0.972
source quote (p.8)
“high Area Under the Curve (AUC) of the Receiver Operating Characteristic (ROC) curve (0.961, 95% Bootstrap Confidence Interval: 0.948, 0.972)”
ppvas written: “Positive Predictive Value”0.15CI 0.126, 0.177
source quote (p.9)
“Positive Predictive Value”
npvas written: “Negative Predictive Value”0.997CI 0.995, 0.999
source quote (p.9)
“Negative Predictive Value”
aurocas written: “Reader AUC improvement”0.0797CI 0.0797, 0.0798
source quote (p.10)
“Reader AUC improvement for interstitial thickening was 0.0797 (95% Confidence Interval: 0.0797, 0.0798).”

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
1
drift signals on this device
  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K230085 (decision 2023-10-03) from Imagen Technologies, Inc for a matching device line ("Lung-CAD") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K230085

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/K223811