Contour ProtégéAI

K213976

MIM Software Inc. · cleared 2022-02-03 · product code QKB · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.4)
“Contour ProtégéAI is an accessory to MIM software. It includes processing components to allow the contouring of anatomical structures using machine-learning-based algorithms automatically.”
Algorithmmachine-learning algorithms
source quote (p.3)
“Creation of contours using machine-learning algorithms for applications including, but not limited to, quantitative analysis, aiding adaptive therapy, transferring contours to radiation therapy treatment planning systems, and archiving contours for patient follow-up and management.”
Adaptive (vs locked)No
PCCPNo
Cybersecurity addressedNo

Validation studies (1)

Retrospective clinical

n=739 images · 12 site(s)

endpoints: Dice coefficient; Equivalence to predicate device

Reported performance (1 observation)

diceas written: “Dice coefficient (A_Aorta_Desc)”0.78CI 0.07 (0.68)
source quote (p.12)
“A_Aorta_Desc 0.78 ± 0.07 (0.68) *”

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
4
drift signals on this device
  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K253270 (decision 2026-03-27) from Mim Software, Inc. for a matching device line ("Contour ProtégéAI+") — a new clearance for the same line is a change event. The newer clearance's parsed summary mentions a PCCP.

    first seen 2026-07-08 · k_number:K253270

  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K250035 (decision 2025-02-03) from MIM Software Inc. for a matching device line ("Contour ProtégéAI+") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K250035

  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K231765 (decision 2023-11-08) from MIM Software Inc. for a matching device line ("Contour ProtégéAI") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K231765

  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K223774 (decision 2023-04-06) from MIM Software Inc. for a matching device line ("Contour ProtégéAI") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K223774

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/K213976