# K260086: CadAI-B Dx

- Pathway: 510(k) (Traditional)
- Applicant: BeamWorks, Inc.
- Decided: Aug 12, 2026 after 212 days
- Product code: QDQ (Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer)
- Device class: 2
- Regulation: 21 CFR 892.2090
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K913770 (1991). 79 ancestors in all.
No later device cites it as a predicate yet.
0 of 80 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210670: BU-CAD, Taihao Medical, Inc. (2021) Summary page 6.

## Indications for use
CadAI-B Dx is a software application indicated to assist interpreting physicians in analyzing the breast ultrasound images of patients with soft tissue breast lesions suspicious for breast cancer who are being referred for further diagnostic ultrasound examination. Output of the device includes lesion indicators placed on breast ultrasound images assisting physicians to identify suspicious soft tissue breast lesions from given B-Mode ultrasound images and the risk analysis of malignancy. The risk analysis of malignancy indicates the malignancy score (CadAI-Score) and corresponding BI-RADS categories. In addition, CadAI-B Dx analyzes the size of the lesions and BI-RADS lexicon descriptors: shape, orientation, margin, echo pattern, and posterior features. CadAI-B Dx may also be used as an image viewer of digital ultrasound images. The software includes tools that allow users to adjust, measure and document images, and output into a structured report. Patient management decisions should not be made solely on the basis of analysis by CadAI-B Dx. Limitations: CadAI-B Dx is not to be used on sites of post-surgical excision, or images with Doppler, elastography, or other overlays present in them.

Source page: https://510kreport.com/device/K260086
Methodology: https://510kreport.com/methodology