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.”
AlgorithmAI algorithms, deep learning algorithm, machine learning based contouring, atlas algorithm (contour registration)
source quote (p.6)
“As advised by the FDA the new product code, QKB, has been created in-lieu of LLZ which uses AI algorithms and is intended for radiation therapy, and is the proposed product code for ART-Plan. 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 (7)

Bench

sample size not stated

endpoints: acceptable contours for the concerned structures on an image of a patient

standards: AAPM requirements

Bench

sample size not stated

endpoints: acceptable contours for the concerned structures on an image of a patient

Bench

sample size not stated

endpoints: acceptable contours for the concerned structures on an image of a patient

Bench

sample size not stated

endpoints: acceptable contours for the patient's body on an image of a patient

standards: AAPM requirements

Bench

sample size not stated

endpoints: quality of the rigid and deformable registration tools of the SmartFuse module on retrospective intra-patient images and inter-patient images of different modalities, to ensure the safety of the device for clinical use.

standards: AAPM recommendations

Bench

sample size not stated

endpoints: quality of the deformable registration tools of the SmartFuse module on intra-patient CT images.

standards: POPI-model protocol

Bench

sample size not stated

endpoints: clinically acceptable contours for the concerned structures when applied to US patients.

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
2
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); 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/K202700