RevealAI-Lung

K251769

Precision Medical Ventures, Inc. Dba Revealdx · cleared 2026-01-30 · product code POK · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.7)
“RevealAI-Lung is a software only device.”
Algorithmmachine learning algorithm trained on features calculated from nodules in the NLST database where diagnoses were confirmed; extracts thousands of machine vision features from CT images and uses machine learning techniques to relate these features to confirmed diagnoses within the reference dataset; provides an mSI score for relative malignancy risk with a scale of 0 to 1.
source quote (p.6)
“The mSI value is expressed as a numeric value from 0 to 1 based on a machine learning algorithm trained on features calculated from nodules in the NLST database where diagnoses were confirmed.Internally RevealAI-Lung extracts thousands of machine vision features from the CT, and machine learning techniques were used to relate these features to confirmed diagnoses within the reference dataset.RevealAI-Lung provides an mSI score for relative malignancy risk with a scale of 0 to 1, with 0 representing lowest risk and 1 highest risk.”
Adaptive (vs locked)No
source quote (p.17)
“The only augmentation to this dataset was to vary the spatial coordinate corresponding to the nodule center.”
PCCPFDA source did not state this
Cybersecurity addressedYes
source quote (p.19)
“Cybersecurity activities were performed using FDA's “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions; Guidance for Industry and Food and Drug Administration Staff” (Document issued on September 27, 2023)”

Validation studies (2)

Reader study (MRMC)

n=108 cases · 4 site(s)

endpoints: ability of the readers to discriminate between malignant and benign pulmonary nodules from CT images only, with and without the aid of the mSI; area under the receiver operating characteristic curve (AUC) across all cases; effect size of the mSI intervention measured as the difference in AUC before and after consulting the malignancy score provided by the mSI

standards: ISO 14971:2019 Application of Risk Management to Medical Devices

Retrospective clinical

n=675 patients · 3 site(s)

Reported performance (5 observations)

sensitivity0.82CI ± 0.036
source quote (p.24)
“Use of RevealAI-Lung increased sensitivity by 14 points (0.68 ± 0.039 to 0.82 ± 0.036)”
specificity0.467CI ± 0.043
source quote (p.24)
“and specificity by 12 points (0.344 ± 0.041 to 0.467 ± 0.043).”
aurocas written: “auc”0.719
source quote (p.23)
“With Reveal AUC = 0.719”
aurocas written: “AUC without device”0.538
source quote (p.23)
“Without AUC = 0.538”
aurocas written: “AUC improvement (Delta)”0.181
source quote (p.23)
“Mean: 0.181”

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/K251769