ART-Plan+ (v3.1.0)

K253091

Therapanacea Sas · cleared 2025-12-23 · product code MUJ · Radiology

Premarket evidence — what FDA accepted

Device typesamd

source quote (p.9)

“Standalone software application accessed via a compliant browser (Chrome, Mozilla Firefox and Edge) on a personal computer, tablet or phone”

AlgorithmDeep learning algorithm

source quote (p.10)

“Deep learning algorithm.”

Adaptive (vs locked)FDA source did not state this

PCCPNo

Cybersecurity addressedNo

Validation studies (1)

Standalone

n=2,040 patients

endpoints: Dice Similarity Coefficient (DSC); effectiveness difference (%) in DVH achieved goals; clinical acceptable automatic plans; Median 2%/2mm; Median 3%/3mm; median dose deviation; Jacobian determinant; qualitative evaluation of the overall registration output; qualitative evaluation of the propagated contours

Reported performance (1 observation)

diceas written: “Mean DSC (annotate)”0.8

source quote (p.12)

“Mean DSC (annotate) ≥ 0.8”

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

-50%

vs code's own 3-yr baseline

drift signals on this device

recall_reason_pattern
Software/algorithm-related recall in product code MUJ (Philips Medical Systems (Cleveland) Inc, initiated 2025-08-05): "Due to a software issue, there is a potential image error of the Region of Interest for expansion/contraction for HFP (Head First Prone), FFS (Feet First Supine) and FFP (Feet Firs" Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:97049
recall_reason_pattern
Software/algorithm-related recall in product code MUJ (Philips Medical Systems (Cleveland) Inc, initiated 2025-07-17): "Due to software issue, Radiation Therapy Planning system may provide incorrect dataset calculations when performing the "Stopping Power Ratio" (SPR) ," Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:97309

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).