ART-PLAN

K220813

TheraPanacea · cleared 2022-06-17 · 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.”

AlgorithmAI-based contouring, deep-learning based automatic segmentation

source quote (p.3)

“ART-Plan supports AI-based contouring on CT and MR images and offers semi-automatic and manual tools for segmentation.”

Adaptive (vs locked)No

PCCPFDA source did not state this

Cybersecurity addressedFDA source did not state this

Validation studies (3)

Retrospective clinical

n=8,736 patients

endpoints: Dice Similarity Coefficient (DSC); inter-expert variability (DSC); clinicians' qualitative evaluation (A+B %); 2%/2mm gamma passing criteria; 3%/3mm gamma passing criteria; mean dose deviation (pseudo-CT compared to standard CT)

Bench

sample size not stated

standards: IEC 62366-1:2015+AMD1:2020

Bench

sample size not stated

Reported performance (1 observation)

diceas written: “Dice Similarity Coefficient (DSC)”stated without value

source quote (p.26)

“Mean DSC of each organ was compared with the tolerance threshold of 0.8. After comparing the contours of 3 different experts on the same patient the mean DSC was calculated, compared with the auto-segmentation and was observed to be in every case superior.”

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

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).