ART-Plan

THERAPANACEA · Model V2.X · UDI-DI 03770019940013

QKB MUJ Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

The current version of the medical device includes the Annotate, SmartFuse and AdaptBox modules. The Annotate module intends to help the practitioner to delineate organs at risks manually, semi-automatically and automatically. The Smartfuse module is also providing the possibility to do a fusion of images from different modalities. The Adaptbox module is a helping tool to decide if a replanning is necessary. For this purpose, the module allows the user to generate a synthetic-CT from a CBCT image, to auto-delineate regions of interest on the synthetic-CT, to compute the dose on both planning CT and synthetic-CT and then define if there is a need for replanning by comparing volume and dose metrics computed on both images and over the course of the treatment. Those metrics are defined by the user. This version also contains an administration module, that allows the user to manage data and rights.

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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.