AutoContour

K200323

Radformation, Inc. · cleared 2020-10-30 · product code QKB · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.7)
“None - software only application. The software application does not deliver or depend on energy delivered to or from patients”
AlgorithmMachine learning based contouring
source quote (p.7)
“Machine learning based contouring and manual ROI manipulation.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this

Validation studies (1)

Bench

sample size not stated

endpoints: performance as intended per its indications for use; generalizability of the machine learning model; software works as intended; pass/fail criteria were used to verify requirements

Reported performance (0 observations)

FDA source did not state a quantitative performance metric — non-reporting is itself the signal.

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) K260509 (decision 2026-03-19) from Radformation, Inc. for a matching device line ("AutoContour (RADAC V5)") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K260509

  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K242729 (decision 2024-12-09) from Radformation, Inc. for a matching device line ("AutoContour (Model RADAC V4)") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K242729

  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K230685 (decision 2023-04-14) from Radformation, Inc. for a matching device line ("AutoContour Model RADAC V3") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K230685

  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K220598 (decision 2022-08-24) from Radformation, Inc. for a matching device line ("AutoContour Model RADAC V2") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K220598

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/K200323