# K251351: AccuContour 4.0

- Pathway: 510(k) (Traditional)
- Applicant: Manteia Technologies Co., Ltd.
- Decided: Jan 23, 2026 after 268 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
It is used by radiation oncology department to segment CT images, to generate needed information for treatment planning, treatment evaluation and treatment adaption.

Source page: https://510kreport.com/device/K251351
Methodology: https://510kreport.com/methodology