Livermoretech, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Livermoretech, Inc.” (first 2018, latest 2025), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 114 days. Since 2017 the median was 114 days, against 63 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2018 | 1 | 65 |
| 2019 | 1 | 253 |
| 2020 | 3 | 88 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 1 | 148 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Livermoretech, Inc. took a median 114 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 63 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| IZL | System, X-Ray, Mobile | 2 | 2 |
| EHD | Unit, X-Ray, Extraoral With Timer | 1 | 1 |
| KPR | System, X-Ray, Stationary | 1 | 1 |
| MQB | Solid State X-Ray Imager (Flat Panel/Digital Imager) | 1 | 1 |
| OWB | Interventional Fluoroscopic X-Ray System | 1 | 1 |
Review panels
- Radiology (6)
Most recent Livermoretech, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K244049 | Europa (Alternative: AiRTouch) portable X-ray system | IZL | 2025-05-28 | 148 |
| K193535 | EZER, Portable X-ray System | IZL | 2020-05-07 | 139 |
| K200022 | FLUSION-9001, Fluoroscopic C-arm Mobile X-ray System | OWB | 2020-04-03 | 88 |
| K193644 | E-COM DR-2000 DR | MQB | 2020-02-14 | 46 |
| K190935 | EZER, Portable X-ray System | EHD | 2019-12-19 | 253 |
| K180663 | LaVid FMTS DIAGNOSTIC X-RAY SYSTEM | KPR | 2018-05-18 | 65 |
Recalls
openFDA lists no recalls under a recalling firm named Livermoretech, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Livermoretech, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Livermoretech, Inc.” (first 2018, latest 2025), across 5 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Livermoretech, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Livermoretech, Inc. is 114 days. Since 2017: 114 days, versus 63 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Livermoretech, Inc.?
The most frequent FDA product codes under this applicant name are IZL (System, X-Ray, Mobile, 2); EHD (Unit, X-Ray, Extraoral With Timer, 1); KPR (System, X-Ray, Stationary, 1).
Next steps
- See all 6 Livermoretech, Inc. clearances with predicates and recalls
- Run predicate analysis for product code IZL, Livermoretech, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.