# K252190: DeepBT Detector-Plus

- Pathway: 510(k) (Traditional)
- Applicant: Aitewan Biomedical Technology, Inc.
- Decided: Apr 10, 2026 after 270 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)
- K203235: VBrain, Vysioneer, Inc. (2021) Summary page 5.

## Indications for use
DeepBT Detector-Plus is a software system intended to assist trained medical professionals, during their clinical workflows of radiation therapy treatment planning, by providing initial object contours of diagnosed brain tumors (i.e., region of interest, ROI). The system can utilize both axial T1-weighted contrast-enhanced brain MRI images (T1W+C) and T2-weighted (T2W) MRI images, allowing the model to reference both imaging sequences simultaneously. The generated contours are applied on the T1W+C images, which serve as the primary imaging reference for radiation therapy treatment planning. DeepBT Detector-Plus, which utilizes an artificial intelligence algorithm (i.e., deep learning neural networks), is intended to be used only on adult patients for generating Gross Tumor Volume (GTV) contours of brain metastases, meningiomas, and acoustic neuromas; It is not intended to be used with images of other types of brain tumors. When inputting images, DeepBT Detector-Plus can take either single-parameter images (T1W+C) or bi-parameter images (T1W+C and T2W) for interpretation. Medical professionals must finalize (confirm or modify) the contours generated by DeepBT Detector-Plus using an external platform available at the facility that supports DICOM-compatible viewing and editing, such as a Treatment Planning System (TPS) or a DICOM-compliant workstation, before using them for treatment.

Source page: https://510kreport.com/device/K252190
Methodology: https://510kreport.com/methodology