Radiology · 510(k) · 2021
ART-Plan
TheraPanacea. Cleared by FDA on 14 January 2021 under submission K202700, product code QKB (radiological image processing software for radiation therapy). What FDA's record says, in FDA's words.
Device record · K202700
- Device. ART-PlanDEVICE
- Company. TheraPanacea (FR)COMPANY
- Decision. 14 January 2021, 510(k), substantially equivalent (traditional review); received 16 September 2020DECISION
- Panel. RadiologyPANEL
- Product code. QKB, Radiological Image Processing Software For Radiation TherapyCODE
- Regulation. 21 CFR 892.2050, Class IIREG
- Source. FDA database entry · decision document (22 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.
ART-Plan is a software designed to assist the contouring process of the target anatomical regions on 3D-images of cancer patients for whom radiotherapy treatment has been planned. The SmartFuse module allows the user to register combinations of anatomical and functional images and display them with fused and non-fused displays to facilitate the comparison and delineation of image data by the user. The images created with rigid or elastic registration require verifications, potential modifications, and then the validation of a trained user with professional qualifications in anatomy and radiotherapy. With the Annotate module, users can edit manually and semi-automatically the contours for the regions of interest. It also allows to generate automatically, and based on medical practices, the contours for the organs at risk and healthy lymph nodes on CT images. The contours created automatically, semi-automatically or manually require verifications, potential modifications, and then the validation of a trained user with professional qualifications in anatomy and radiotherapy. The device is intended to be used in a clinical setting, by trained professionals only.
The product code's definition, from FDA's classification record. To provide semi-automatic or fully-automated radiological image processing and analysis tools for radiation therapy. Software implementing artificial intelligence (AI) including nonadaptive machine learning algorithms trained with clinical and/or artificial radiological images. In these devices, the algorithm training images typically impact device performance. AI based radiological image processing software is intended to be used in the workflow of radiation therapy. Adaptive AI algorithms are not within the scope of this product code. Primary radiation dose calculation or plan optimization for treatment planning are not within scope of this product code.
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
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 0 reports filed against devices carrying product code QKB. 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.
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.
More devices under product code QKB, in Radiology, from TheraPanacea, or cleared in 2021. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.