# K203502: MEDO-Thyroid

- Pathway: 510(k) (Traditional)
- Applicant: Medo DX Pte., Ltd.
- Decided: Apr 23, 2021 after 144 days
- Product code: QIH (Automated Radiological Image Processing Software)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K91647: QLAB Advanced Quantification Software. Number could not be read Summary page 4.

## Most influential descendants
- K230497: Bladder AI (AIBV01) (2023), 2 descendants of its own
- K232257: Clarius Bladder AI (2023), 1 descendant of its own
- K243853: Clarius Prostate AI (2025), 0 descendants of its own

## Indications for use
MEDO-Thyroid is designed to view and quantify ultrasound thyroid image data using machine learning techniques to aid in analysis of thyroid lobes and identify thyroid nodules, including evaluation, quantification and documentation of any such nodule. The device is intended to be used on adult patient images of 18 years or older.

Source page: https://510kreport.com/device/K203502
Methodology: https://510kreport.com/methodology