# K250780: ARTAssistant

- Pathway: 510(k) (Traditional)
- Applicant: Manteia Technologies Co., Ltd.
- Decided: Dec 5, 2025 after 266 days
- Product code: QKB (Radiological Image Processing Software For Radiation Therapy)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 16 generations back to K954874 (1996). 102 ancestors in all.
No later device cites it as a predicate yet.
1 of 103 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K221706: AccuContour, Manteia Technologies Co., Ltd. (2023) Summary page 5.

## Indications for use
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.

Source page: https://510kreport.com/device/K250780
Methodology: https://510kreport.com/methodology