ART-Plan
K230023Therapanacea SAS · cleared 2023-04-19 · product code QKB · Radiology
Premarket evidence — what FDA accepted
source quote (p.3)
“ART-Plan is a software application intended to display and visualize 3D multi-modal medical image data. The user may mport, define, display, transform and store DICOM3.0 compliant datasets (including regions of interest structures).”
source quote (p.3)
“ART-Plan supports AI-based contouring on CT and MR images and offers semi-automatic and manual tools for segmentation.”
source quote (p.12)
“Once convergence is achieved, the model is considered ready to be tested and clinically validated on a different, yet representative data set, following a well-established process of validation that has already been submitted to and cleared by the FDA.”
Validation studies (1)
Retrospective clinical
n=8,736 patients
endpoints: Dice Similarity Coefficient (DSC) mean; DSC (mean) ≥ mean (DSC inter-expert) + 5%; Clinicians' qualitative evaluation (A+B %)
standards: AAPM
Reported performance (31 observations)
source quote (p.17)
“DICE diff inter-expert=6.58%”
source quote (p.17)
“DICE diff inter-expert=15.56%”
source quote (p.17)
“DICE diff inter-expert=14.75%”
source quote (p.17)
“DICE diff inter-expert=6.17%”
source quote (p.17)
“DICE diff inter-expert=0%”
source quote (p.17)
“DICE diff inter-expert=1.06%”
source quote (p.18)
“DICE diff inter-expert=3.61%”
source quote (p.18)
“DICE diff inter-expert=22.64%”
source quote (p.18)
“DICE diff inter-expert=7.41%”
source quote (p.18)
“DICE diff inter-expert=-1.10%”
source quote (p.18)
“DICE diff inter-expert=1.08%”
source quote (p.18)
“DICE diff inter-expert=2.27%”
source quote (p.18)
“DICE diff inter-expert=9.59%”
source quote (p.21)
“DICE diff inter-expert=6.47%”
source quote (p.21)
“DICE diff inter-expert=19.96%”
source quote (p.21)
“DICE diff inter-expert=7.93%”
source quote (p.21)
“DICE diff inter-expert=4.19%”
source quote (p.21)
“DICE diff inter-expert=4.76%”
source quote (p.21)
“DICE diff inter-expert=12.26%”
source quote (p.21)
“DICE diff inter-expert=-1.20%”
source quote (p.22)
“DICE diff inter-expert=3.25%”
source quote (p.22)
“DICE diff inter-expert=5.78”
source quote (p.22)
“DICE diff inter-expert=3.39%”
source quote (p.22)
“DICE diff inter-expert=2.07%”
source quote (p.22)
“DICE diff inter-expert=29.22%”
source quote (p.22)
“DICE diff inter-expert=4.66%”
source quote (p.22)
“DICE diff inter-expert=3.32%”
source quote (p.23)
“DICE diff inter-expert=4.23%”
source quote (p.23)
“DICE diff inter-expert=10.03%”
source quote (p.23)
“DICE diff inter-expert=3.08%”
source quote (p.23)
“DICE diff inter-expert=13.01%”
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
- 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). 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).