Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Livermoretech, Inc. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
139 daysmedian FDA review time
253 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K244049 | Europa (Alternative: AiRTouch) portable X-ray system | Livermoretech, Inc. | 2025-05-28 | 148 | 0 |
| K193535 | EZER, Portable X-ray System | Livermoretech, Inc. | 2020-05-07 | 139 | 0 |
| K200022 | FLUSION-9001, Fluoroscopic C-arm Mobile X-ray System | Livermoretech, Inc. | 2020-04-03 | 88 | 0 |
| K193644 | E-COM DR-2000 DR | Livermoretech, Inc. | 2020-02-14 | 46 | 0 |
| K190935 | EZER, Portable X-ray System | Livermoretech, Inc. | 2019-12-19 | 253 | 0 |
| K180663 | LaVid FMTS DIAGNOSTIC X-RAY SYSTEM | Livermoretech, Inc. | 2018-05-18 | 65 | 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