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 (Substantially Equivalent)”

Algorithmmachine learning based contouring

source quote (p.7)

“Machine learning based contouring and manual ROI manipulation. (Subject Device”

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

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

recalls in product code, 24mo

MAUDE reports in code, 12mo

—

vs code's own 3-yr baseline

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). 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).