DeepContour (V1.0)

K232928

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

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 2026-07-08.

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/K232928