DeepContour (V1.0)

K232928

Wisdom Technologies., Inc. · cleared 2024-05-07 · product code QKB · Radiology

FDA 510(k) summary for DeepContour (V1.0) (K232928)

Constat organizes this clearance into predicate context, validation evidence, reported performance, postmarket signals, and reimbursement links. Each extracted claim stays tied to the public FDA source; missing fields remain explicitly unstated.

Validation studies
2
Cited predicates
2
Performance observations
1
Product code
QKB
Official FDA 510(k) database record ↗FDA 510(k) source PDF ↗

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.3)
“DeepContour is a deep learning based medical imaging software that allows trained healthcare professionals to use DeepContour as a tool to automatically process CT images.”
Algorithmdeep learning based medical imaging software
source quote (p.3)
“DeepContour is a deep learning based medical imaging software that allows trained healthcare professionals to use DeepContour as a tool to automatically process CT images.”
Adaptive (vs locked)No
PCCPNo
Cybersecurity addressedNo

Validation studies (2)

Retrospective clinical

n=100 cases · 1 site(s)

endpoints: Dice coefficients; MAE; RMSE; PSNR; SSIM

standards: RTOG and clinical guidelines

Retrospective clinical

n=103 patients

endpoints: Dice coefficients; ASSD

Reported performance (1 observation)

diceas written: “Dice coefficient (Brain)”0.98CI 0.97
source quote (p.14)
“Brain 0.98±0.01(0.97)”

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 2026-08-26.

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.

Related FDA clearances

More AI/ML devices under product code QKB

These are recent clearances in the same FDA product-code category. Shared classification does not by itself make a device an appropriate predicate.

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TAIMedImg DeepMets

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Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K232928