Radiology · 510(k) · 2026
DeepBT Detector-Plus
Aitewan Biomedical Technology, Inc.. Cleared by FDA on 10 April 2026 under submission K252190, product code QKB (radiological image processing software for radiation therapy). What FDA's record says, in FDA's words.
Device record · K252190
- Device. DeepBT Detector-PlusDEVICE
- Company. Aitewan Biomedical Technology, Inc. (TW)COMPANY
- Decision. 10 April 2026, 510(k), substantially equivalent (traditional review); received 14 July 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 (13 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.
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.
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 namedMRI
- Mentionsdetection or identification of findings
- Mentionsmeasurement or quantification
- Mentionsadult patients
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, or cleared in 2026. 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.