510(k) Report

FDA applicant

Livermoretech, Inc.

Plano, TX6 decisions2018–20250 recalls

FDA records 6 decisions for Livermoretech, Inc. (Plano, TX) from 2018 to 2025: 6 510(k) clearances. Most are in product codes IZL (System, X-Ray, Mobile) and OWB (Interventional Fluoroscopic X-Ray System). Since 2016 its 510(k)s took a median of 114 days from receipt to decision, against 48 for FDA’s reviews in the same codes and years. Its devices cite 5 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, radiology panel, where it files most

How often FDA has decided Livermoretech, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2018: 12019: 12020: 32025: 1
2018high 3 (2020) · low 0 (2021)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2018.

FIG. 1 — Livermoretech, Inc. by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • IZLSystem, X-Ray, Mobile2decisions
  • OWBInterventional Fluoroscopic X-Ray System1decision
  • KPRSystem, X-Ray, Stationary1decision
  • EHDUnit, X-Ray, Extraoral With Timer1decision
  • MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)1decision

How long do its 510(k) reviews take?

Since 2016, its 6 510(k)s took a median of 114 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 48 days; 1 of its 6 were faster than that.

Whose devices does it build on?

Its devices cite 5 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 1 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K193535EZER, Portable X-ray SystemLivermoretech, Inc. · 20202cite it
  • K193644E-Com DR-2000 DRLivermoretech, Inc. · 20201cites it

What has FDA decided for it lately?

  • K244049Europa (Alternative: AiRTouch) portable X-ray systemLivermoretech, Inc. · 2025
  • K193535EZER, Portable X-ray SystemLivermoretech, Inc. · 2020
  • K200022FLUSION-9001, Fluoroscopic C-arm Mobile X-ray SystemLivermoretech, Inc. · 2020
  • K193644E-Com DR-2000 DRLivermoretech, Inc. · 2020
  • K190935EZER, Portable X-ray SystemLivermoretech, Inc. · 2019
  • K180663LaVid FMTS DIAGNOSTIC X-RAY SYSTEMLivermoretech, Inc. · 2018

All 6 as Livermoretech, Inc. →