ART-Plan

The current version of the medical device includes the Annotate, SmartFuse, SmartPlan and AdaptBox modules. The Annotate module allow the contouring of regions of interest. The module…

Registry build 21.09.26

The current version of the medical device includes the Annotate, SmartFuse, SmartPlan and AdaptBox modules. The Annotate module allow the contouring of regions of interest. The module Smartplan allows the creation of an automatic treatment plan based on a planning CT and a RTSS 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.

2manufacturers in China registered for this device type
3catalogue numbers in this listing
3510(k) clearances naming this product code

Who Else Makes It

Concentrated in Fujian (1), Beijing (1).

Chinese manufacturers registered for FDA product code QKB
Manufacturer City Province Registered as Device types
Manteia Technologies Co., Ltd. Xiamen Fujian Manufacturer 3
Medmind Technology Co., Ltd. Beijing Beijing Manufacturer 1

Record

Regulatory record for ART-Plan
Listed by Therapanacea, France
FDA product code QKB
Device type Radiological Image Processing Software For Radiation Therapy
Device class Class 2
Regulation 21 CFR 892.2050
Establishment Manufacturer
510(k) K232479
Record published 2025-12-10

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Prescription Prescription only
Label carries lot or batch number, manufacturing date

Catalogue Numbers

Catalogue numbers for ART-Plan
Catalogue number Size Status
V2.X In distribution
v.1.10.0 In distribution
V3.X In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
AI-Rad Companion Organs RT Siemens Healthcare Limited 6
AccuContour Manteia Technologies Co., Ltd. 4
ContourProtégéAI MIM Software Inc. 3
AutoContour Radformation, Inc. 2
DeepContour Wisdom Medical Technologies 1
ContourProtégéAI – CT Abdomen MIM Software Inc. 1
VBrain Vysioneer, Inc. 1
ContourProtégéAI – MR Prostate MIM Software Inc. 1
RT-Mind-AI Medmind Technology Co., Ltd. 1
MRI Planner Spectronic Medical AB 1
ContourProtégéAI – CT Prostate MIM Software Inc. 1
Aview RT ACS Coreline Soft Co., Ltd. 1

Showing 12 of 25. All products under Radiological Image Processing Software For Radiation Therapy

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K230023 2023-04-19
K220813 2022-06-17
K202700 2021-01-14

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer