V5med Lung AI

K242919

V5med Inc. · cleared 2025-03-27 · product code OEB · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.4)
“V5med Lung AI is a Computer-Aided Detection (CAD) software designed to assist radiologists in detecting pulmonary nodules (with diameter of 4-30 mm) during CT examinations of the chest for asymptomatic populations.”
AlgorithmDeep Convolutional Neural Network (CNN) based algorithm
source quote (p.6)
“The detection model is trained using a Deep Convolutional Neural Network (CNN) based algorithm, enabling automatic detection of lung nodules ranging from 4 to 30 mm in chest CT images.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this

Validation studies (1)

Reader study (MRMC)

n=340 cases

endpoints: area under the curve (AUC) of the localization-specific receiver operating characteristic (LROC) response; Radiologist interpretation times

standards: General Principles of Software Validation; Final Guidance for Industry and FDA Staff (January 11, 2002), Guidance for the Content of Premarket Submissions for Device Software Functions. (June 14, 2023), IEC 62304:2006/Amd 1:2015 - Medical device software-software life cycle processes

Reported performance (3 observations)

aurocas written: “auc”0.83
source quote (p.11)
“AUC 0.830”
aurocas written: “AUC (Unaided)”0.734
source quote (p.11)
“AUC 0.734”
aurocas written: “AUC Difference (Aided-Unaided)”0.0959CI (0.0586, 0.1332)
source quote (p.11)
“Difference (95%CI) 0.0959 (0.0586, 0.1332)”

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
—
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/K242919