510(k) · Cleared
ClearedMEDO-Thyroid
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medo DX Pte., Ltd. · QIH Automated Radiological Image Processing Software
Cleared on Apr 23, 2021 after a 144-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 3 later devices descend from it.
- Decided
- Apr 23, 2021
- Review
- 144 days
- Class
- Class II
- Product code
- QIH
- Recalls
- None
- Predicates
- 1
3 later devices descend from it, 1 citing it directly.
- This deviceK203502 MEDO-ThyroidMedo DX Pte., Ltd. · 2021
- Descendant · cites it directly · 2 of its ownK230497 Bladder AI (AIBV01)Exo, Inc. · 2023
- Descendant · 2 generations on · 1 of its ownK232257 Clarius Bladder AIClarius Mobile Health Corp. · 2023
- Descendant · 3 generations on · 0 of its ownK243853 Clarius Prostate AIClarius Mobile Health Corp. · 2025
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K203502 | MEDO-Thyroid | Medo DX Pte., Ltd. | 2021 | — |
| +1 | K230497 | Bladder AI (AIBV01) | Exo, Inc. | 2023 | — |
| +2 | K232257 | Clarius Bladder AI | Clarius Mobile Health Corp. | 2023 | — |
| +3 | K243853 | Clarius Prostate AI | Clarius Mobile Health Corp. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 2 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QIH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new QIH device
- #1 K213998 cvi42 Auto Imaging Software Applicationscore 23.5 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K91647 | QLAB Advanced Quantification Software Number could not be read Summary page 4…QIH Regulatory Class II 5.3. Predicate Device Proprietary Name QLAB Advanced Quantification Software Common Name Kl91647 Classification Name Automated Radiological Image Processing Software Regulation Number 21 CFR 892.2050 Pr… |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K230497 | Bladder AI (AIBV01) | 2023 | 2 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K230497 (Exo, Inc., 2023) has gone furthest, with 2 descendants of its own.
How does its category compare?
All QIH devicesQIH Automated Radiological Image Processing Software: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · QIH
94in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QIH
150in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QIH
1so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · QIH
4in 2025
MAUDE reports naming product code QIH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 11 | 145 | 0 | 0 |
| 2021 | 19 | 125 | 0 | 0 |
| 2022 | 25 | 134 | 0 | 0 |
| 2023 | 45 | 151 | 0 | 0 |
| 2024 | 64 | 141 | 0 | 2 |
| 2025 | 94 | 150 | 0 | 4 |
| 2026 | 78 | 130 | 1 | — |
What is it indicated for?
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K203502 · printed Nov 5, 2026
Cite this page
510(k) Report. “K203502: MEDO-Thyroid.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K203502
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026