VisiRad XR

K223133

Imidex Inc. · cleared 2023-08-03 · product code MYN · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.4)
“VisiRad XR is a computer aided detection (CADe) software as a medical device (SaMD) product intended to detect lung nodules and masses from 6-60mm in chest radiographs.”
AlgorithmMachine learning
source quote (p.6)
“Machine learning”
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)

Standalone

sample size not stated · 3 site(s)

endpoints: device sensitivity calculated at an image level; Area Under the Curve (AUC) of the Receiver Operating Characteristic (ROC) curve

Reader study (MRMC)

n=600 images · 2 site(s)

endpoints: accuracy of readers aided by VisiRad XR as determined by the image-level Area Under the Curve (AUC) of the Receiver Operating Characteristic (ROC) curve; sensitivity; specificity

Reported performance (3 observations)

sensitivity0.83CI 95% CI: 0.81-0.84
source quote (p.7)
“Study results demonstrated an overall sensitivity of 0.83 (95% CI: 0.81-0.84) with average false positives per image of 1.5.”
aurocas written: “auc”0.73CI 95% CI: 0.71-0.74
source quote (p.7)
“Overall AUC, calculated non-parametrically, was 0.73 (95% CI: 0.71-0.74).”
false_positive_rate_per_imageas written: “average false positives per image”1.5
source quote (p.7)
“Study results demonstrated an overall sensitivity of 0.83 (95% CI: 0.81-0.84) with average false positives per image of 1.5.”

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/K223133