ART-Plan

K202700

TheraPanacea · cleared 2021-01-14 · product code QKB · Radiology

Premarket evidence — what FDA accepted

Device typesamd

source quote (p.3)

“ART-Plan is a software designed to assist the contouring process of the target anatomical regions on 3D-images of cancer patients for whom radiotherapy treatment has been planned.”

AlgorithmDeep learning algorithm

source quote (p.16)

“Deep learning algorithm.”

Adaptive (vs locked)FDA source did not state this

PCCPFDA source did not state this

Cybersecurity addressedFDA source did not state this

Validation studies (11)

Bench

sample size not stated

standards: IEC 62366

Bench

sample size not stated

Bench

sample size not stated

standards: AAPM requirements

Bench

sample size not stated

Bench

sample size not stated

Bench

sample size not stated

standards: AAPM requirements

Bench

sample size not stated

standards: AAPM recommendations

Bench

sample size not stated

standards: POPI-model protocol

Bench

sample size not stated

Bench

sample size not stated

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) K232479 (decision 2023-12-22) from TheraPanacea for a matching device line ("ART-Plan") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K232479
re_clearance
The FDA AI/ML device list shows a newer 510(k) K220813 (decision 2022-06-17) from TheraPanacea for a matching device line ("ART-PLAN") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K220813

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).