ART-Plan

GUDID 03770019940013

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.

THERAPANACEA

Radiation therapy software

• Primary Device ID: 03770019940013
• NIH Device Record Key: 8997f5d1-19c6-413a-aac2-effc60b8a16b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ART-Plan
• Version Model Number: V2.X
• Company DUNS: 269366925
• Company Name: THERAPANACEA
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	03770019940013 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K232479

FDA Product Code

• QKB: Radiological Image Processing Software For Radiation Therapy

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-12-18
• Device Publish Date: 2025-12-10

On-Brand Devices [ART-Plan]

• 03770019940006: The current version of the medical device includes the Annotate and the SmartFuse module that in
• 03770019940020: The current version of the medical device includes the Annotate, SmartFuse, SmartPlan and AdaptB
• 03770019940013: The current version of the medical device includes the Annotate, SmartFuse and AdaptBox modules.