# K210670: BU-CAD

- Pathway: 510(k) (Traditional)
- Applicant: Taihao Medical, Inc.
- Decided: Dec 21, 2021 after 291 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: 12 generations back to K913770 (1991). 78 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 82 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181704: Transpara, Screenpoint Medical B.V. (2018) Summary page 4.
- K170195: QuantX, Quantitative Insights, Inc. (2017) Summary page 4.

## Most influential descendants
- K260086: CadAI-B Dx (2026), 0 descendants of its own
- K260303: See-Mode Augmented Reporting Tool, Breast (SMART-B) (2026), 0 descendants of its own
- K240697: See-Mode Augmented Reporting Tool, Thyroid (SMART-T) (2024), 0 descendants of its own

## Indications for use
BU-CAD is a software application indicated to assist trained 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 regions of interest (ROIs) and lesion contours placed on breast ultrasound images assisting physicians to identify suspicious soft tissue lesions from up to two orthogonal views of a single lesion, and region-based analysis of lesion malignancy upon the physician's query. The region-based analysis indicates the score of lesion characteristics (SLC), and corresponding BI-RADS categories in user-selected ROIs or ROIs automatically identified by the software. In addition, BU-CAD also automatically classifies lesion shape, orientation, margin, echo pattern, and posterior features according to BI-RADS descriptors. BU-CAD may also be used as an image viewer of multi-modality digital images, including ultrasound and mammography. The software includes tools that allow users to adjust, measure and document images, and output into a structured report (SR). Patient management decisions should not be made solely on the basis of analysis by BU-CAD. Limitations: BU-CAD is not to be used on sites of post-surgical excision, or images with Doppler, elastography, or other overlays present in them. BU-CAD is not intended for the primary interpretation of digital mammography images. BU-CAD is not intended for use on mobile devices.

Source page: https://510kreport.com/device/K210670
Methodology: https://510kreport.com/methodology