ART-Plan

K230023

Therapanacea SAS · cleared 2023-04-19 · product code QKB · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.3)
“ART-Plan is a software application intended to display and visualize 3D multi-modal medical image data.”
AlgorithmDeep learning algorithm for AI-based contouring
source quote (p.3)
“ART-Plan supports AI-based contouring on CT and MR images and offers semi-automatic and manual tools for segmentation. Deep learning algorithm.”
Adaptive (vs locked)FDA source did not state this
PCCPNo
Cybersecurity addressedNo

Validation studies (2)

Retrospective clinical

n=33 cases

endpoints: DICE diff inter-expert

Retrospective clinical

n=20 cases

endpoints: A: the contour is acceptable for a clinical use without any modification; B: the contour would be acceptable for clinical use after minor modifications/corrections

Reported performance (1 observation)

diceas written: “DICE diff inter-expert”6.58
source quote (p.17)
“DICE diff inter-expert=6.58%”

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
3
drift signals on this device
  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K253091 (decision 2025-12-23) from Therapanacea Sas for a matching device line ("ART-Plan+ (v3.1.0)") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K253091

  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K242822 (decision 2025-02-25) from Therapanacea SAS for a matching device line ("ART-Plan+ (v.3.0.0)") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K242822

  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K234068 (decision 2024-04-22) from Therapanacea SAS for a matching device line ("ART-Plan (v.2.2.0)") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K234068

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/K230023