# K260303: See-Mode Augmented Reporting Tool, Breast (SMART-B)

- Pathway: 510(k) (Traditional)
- Applicant: See-Mode Technologies Pty, Ltd.
- Decided: Jul 28, 2026 after 179 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 7.

## Indications for use
See-Mode Augmented Reporting Tool, Breast (SMART-B) is a stand-alone software to assist trained interpreting physicians in analyzing the breast ultrasound images of patients with soft tissue breast lesions who are being referred for diagnostic ultrasound examination. Output of the device includes regions of interest (ROIs) placed on breast ultrasound images assisting interpreting physicians to localize suspicious soft tissue lesions from two orthogonal views of a single lesion in breast studies. The device also outputs the BI-RADS category as well as the ultrasonographic lexicon-based descriptors based on ACR BI-RADS for breast, including lesion shape, orientation, margin, echo pattern, and posterior features. See-Mode Augmented Reporting Tool, Breast may also be used as a structured reporting software for further ultrasound studies. The software includes tools for reading measurements and annotations from the images that can be used for generating a structured report. Patient management decisions should not be made solely on the basis of analysis by See-Mode Augmented Reporting Tool, Breast.

Source page: https://510kreport.com/device/K260303
Methodology: https://510kreport.com/methodology