ART-Plan

Primary DI
03770019940020
Brand
ART-Plan
Company
THERAPANACEA
Model
V3.X
Device description
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.
Published
2025-12-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
LLZSystem, Image Processing, Radiological
MUJSystem, Planning, Radiation Therapy Treatment
QKBRadiological Image Processing Software For Radiation Therapy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LLZSystem, Image Processing, RadiologicalRadiology2
MUJSystem, Planning, Radiation Therapy TreatmentRadiology2
QKBRadiological Image Processing Software For Radiation TherapyRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K242822000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K242822000ART-Plan+ (v.3.0.0)Therapanacea Sas2025-02-25MUJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03770019940020PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03770019940020037700199400203770019940020

GMDN Terms#

Term, Definition table
TermDefinition
Radiation therapy softwareAn application software program intended to facilitate/support the delivery of therapeutic radiation by enabling computer-assisted functionality in one or more of the following areas: treatment planning, simulation, record/verify, beam block CAD/CAM, quality assurance, and patient positioning. Some types may be combined with specific hardware or firmware accessories or configurations in order to function as intended.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
269366925
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03770019940013ART-PlanV2.X2025-12-10
03770019940006ART-Planv.1.10.02022-10-26

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