Radiology · 510(k) · 2025
ARTAssistant
Manteia Technologies Co., Ltd.. Cleared by FDA on 5 December 2025 under submission K250780, product code QKB (radiological image processing software for radiation therapy). What FDA's record says, in FDA's words.
Device record · K250780
- Device. ARTAssistantDEVICE
- Company. Manteia Technologies Co., Ltd. (CN)COMPANY
- Decision. 5 December 2025, 510(k), substantially equivalent (traditional review); received 14 March 2025DECISION
- 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 (12 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.
Iif it is known. ThisPlease type in the marketing application/submission number, textbox will be left blank for original applications/submissions. Please provide the device trade name(s). I IARTAssistant Please provide your Indications for Use below. The primary function of ARTAssistant is to facilitate image processing with image registration and synthetic CT (sCT) generation in adaptive radiation therapy. This enables users to meticulously design ART plans based on the processed images. I Please select the types of uses (select one or both, as V Prescription Use (Part 21 CFR 801 Subpart D) D Over-The-Counter Use (21 CFR 801 Subpart C)applicable). ARTAssistant 510(k) Summary 1 / 8 510(k) Summary The following information is provided as required by 21 CFR 807.92. The assign 510(k) Number: K250780
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
- Mentionsprescription use
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 Manteia Technologies Co., Ltd., or cleared in 2025. 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.