# K240697: See-Mode Augmented Reporting Tool, Thyroid (SMART-T)

- Pathway: 510(k) (Traditional)
- Applicant: See-Mode Technologies Pte, Ltd.
- Decided: Sep 9, 2024 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, Thyroid (SMART-T) is a stand-alone reporting software to assist trained medical professionals in analyzing thyroid ultrasound images of adult (>=22 years old) patients who have been referred for an ultrasound examination. Output of the device includes regions of interest (ROIs) placed on the thyroid ultrasound images assisting healthcare professionals to localize nodules in thyroid studies. The device also outputs ultrasonographic lexicon-based descriptors based on ACR TI-RADS. The software generates a report based on the image analysis results to be reviewed and approved by a qualified clinician after performing quality control. SMART-T 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, Thyroid.

Source page: https://510kreport.com/device/K240697
Methodology: https://510kreport.com/methodology