# K221706: AccuContour

- Pathway: 510(k) (Traditional)
- Applicant: Manteia Technologies Co., Ltd.
- Decided: Mar 9, 2023 after 269 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: 15 generations back to K954874 (1996). 101 ancestors in all.
2 later devices descend from it; 2 cite it directly.
1 of 104 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191928: AccuContour, Xiamen Manteia Technology, Ltd. (2020) Summary page 4.

## Most influential descendants
- K251351: AccuContour 4.0 (2026), 0 descendants of its own
- K250780: ARTAssistant (2025), 0 descendants of its own

## Indications for use
It is used by radiation oncology department to register multi-modality images and segment (non-contrast) CT images, to generate needed information for treatment planning, treatment evaluation and treatment adaptation.

Source page: https://510kreport.com/device/K221706
Methodology: https://510kreport.com/methodology