Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Qt Ultrasound, LLC · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K190646 | QT Scanner 2000 Model A | Qt Ultrasound, LLC | 2019-10-18 | 219 | 0 |
| K182213 | QT Ultrasound Breast Scanner - 1 | Qt Ultrasound, LLC | 2018-09-14 | 30 | 0 |
| K162372 | QT Ultrasound Breast Scanner-1 | Qt Ultrasound, LLC | 2017-06-06 | 286 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda