Radiology · 510(k) · 2025
ART-Plan+ (v3.1.0)
Therapanacea Sas. Cleared by FDA on 23 December 2025 under submission K253091, product code MUJ (system, planning, radiation therapy treatment). What FDA's record says, in FDA's words.
Device record · K253091
- Device. ART-Plan+ (v3.1.0)DEVICE
- Company. Therapanacea Sas (FR)COMPANY
- Decision. 23 December 2025, 510(k), substantially equivalent (traditional review); received 23 September 2025DECISION
- Panel. RadiologyPANEL
- Product code. MUJ, System, Planning, Radiation Therapy TreatmentCODE
- Regulation. 21 CFR 892.5050, Class IIREG
- Source. FDA database entry · decision document (14 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
if it is known. This K253091Please type in the marketing application/submission number, textbox will be left blank for original applications/submissions. Please provide the device trade name(s). ? IART-Plan+ (v3.1.0 ) Please provide your Indications for Use below. ART-Plan+'s indicated target population is cancer patients for whom radiotherapy treatment has been prescribed. In this population, any patient for whom relevant modality imaging data is available. ART-Plan+'s includes several modules: SmartPlan which allows automatic generation of radiotherapy treatment plan that the users import into their own Treatment Planning System (TPS) for the dose calculation, review and approval. This module is available for supported prescriptions for prostate only. Annotate which allows automatic generation of contours for organs at risk, lymph nodes and tumors, based on medical practices, on medical images such as CT and MR images AdaptBox which allows generation of synthetic-CT from CBCT images, dose computation on CT images for external beam irradiation with photon beams and assisted CBCT-based off-line adaptation decision-making for the following anatomies Head & Neck Breast / Thorax Pelvis (male) ART-Plan+ is not intended to be used for patients less than 18 years of age. The indicated users are trained medical professionals including, but not limited to, radiotherapists, radiation oncologists, medical physicists, dosimetrists, and medical professionals involved in the radiation […]
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Modalities namedCT, MRI
- Mentionsadult patients
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 807 reports filed against devices carrying product code MUJ. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification. The latest reports, in the reporter’s words:
24 September 2026 · Malfunction · MONACO · Elekta Solutions AB · report 3015232217-2026-00031
The customer reported that the SRS Cone plan export for the counter clockwise beam is not being transferred correctly to MOSAIQ.
22 September 2026 · Malfunction · RayStation · RaySearch Laboratories AB (Publ) · report 3007774465-2026-00003
A user was preparing radiotherapy treatment of the right breast for a patient who had previously received RT to the left breast. The user performed a deformable registration of the two CT scans (prior treatment and current) and mapped the dose onto the current planning CT to create a cumulative dose distribution. The user noticed that the dose in the left breast (from the prior treatment) appeared cut off as it was limited by the size of the dose grid used for the prior treatment. The patient […]
22 September 2026 · Malfunction · RayStation · RaySearch Laboratories AB (Publ) · report 3010034862-2026-00003
A user was preparing radiotherapy treatment of the right breast for a patient who had previously received RT to the left breast. The user performed a deformable registration of the two CT scans (prior treatment and current) and mapped the dose onto the current planning CT to create a cumulative dose distribution. The user noticed that the dose in the left breast (from the prior treatment) appeared cut off as it was limited by the size of the dose grid used for the prior treatment. The patient […]
15 July 2026 · Malfunction · PLANONE 1 · COSYLAB, JSC, CONTROL SYSTEM LABORATORY · report 3014425747-2026-00001
DURING TREATMENT PLAN PREPARATION FOR A PATIENT, IT WAS DISCOVERED THAT COUCH SHIFTS (TREATMENT COUCH TRANSLATIONS REQUIRED TO MOVE THE PATIENT FROM THE REFERENCE/SCANNED POSITION TO THE TREATMENT POSITION) DISPLAYED IN PLANONE DIFFERED FROM THOSE DISPLAYED IN ARIA/ECLIPSE WHEN A PLAN CREATED IN PLANONE WAS TRANSFERRED TO ARIA FOR SCHEDULING. NO PATIENT HARM OCCURRED, AS THE INCONSISTENCY WAS IDENTIFIED DURING THE PLAN PREPARATION PHASE BEFORE TREATMENT DELIVERY. INVESTIGATION IDENTIFIED THE […]
2 June 2026 · Malfunction · MONACO · ELEKTA SOLUTIONS AB · report 3015232217-2026-00016
THE CUSTOMER REPORTED THAT THE NUMBERING OF THE FIRST MRI IN MONACO ALWAYS STARTS WITH MR2, AND ONLY THE SECOND MRI THEN BEARS THE NUMBER MR1.
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
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