Contour ProtegeAI

K193252

MIM Software Inc. · cleared 2020-07-02 · product code QKB · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.4)
“Contour ProtégéAI is an accessory to MIM software used for the contouring of anatomical structures in imaging data using machine-learning-based algorithms automatically.”
Algorithmneural networks, machine-learning algorithms
source quote (p.10)
“The neural networks used in the Contour ProtégéAI device were trained on datasets from several large institutions.”
Adaptive (vs locked)FDA source did not state this
PCCPNo
Cybersecurity addressedNo

Validation studies (1)

Retrospective clinical

n=358 images

endpoints: Dice coefficient

Reported performance (1 observation)

diceas written: “mean Dice coefficient”stated without value
source quote (p.11)
“This non-inferiority test compared the mean Dice coefficient of the automatically generated contours for Contour ProtégéAI against that of the predicate device.”

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
1
drift signals on this device
  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K210632 (decision 2021-10-20) from MIM Software Inc. for a matching device line ("Contour ProtegeAI") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K210632

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/K193252