510(k) Report

FDA applicant

Radmedix, LLC

Dayton, OH6 decisions2020–20230 recalls

FDA records 6 decisions for Radmedix, LLC (Dayton, OH) from 2020 to 2023: 6 510(k) clearances. Most are in product codes MQB (Solid State X-Ray Imager (Flat Panel/Digital…) and KPR (System, X-Ray, Stationary). Since 2016 its 510(k)s took a median of 30 days from receipt to decision, against 41 for FDA’s reviews in the same codes and years. Its devices cite 6 predicates, 4 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 Radmedix, LLC’s devices, and how often a recall has named them.

FDA decisions per year

2in 2023

2020: 32021: 12023: 2
2020high 3 (2020) · low 0 (2022)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2020.

FIG. 1 — Radmedix, LLC by year, 2020–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)3decisions
  • KPRSystem, X-Ray, Stationary2decisions
  • IZLSystem, X-Ray, Mobile1decision

How long do its 510(k) reviews take?

Since 2016, its 6 510(k)s took a median of 30 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 41 days; 4 of its 6 were faster than that.

Whose devices does it build on?

Its devices cite 6 predicates; 4 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 7 times; 4 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.

  • K200726AcuityPDRRadmedix, LLC · 20203cite it
  • K210919AcuityDReRadmedix, LLC · 20212cite it
  • K201058Accuvue+Radmedix, LLC · 20201cites it
  • K193360Acuity SDR Standard, Acuity SDR Plus, Acuity FDR StandardRadmedix, LLC · 20201cites it

What has FDA decided for it lately?

  • K231995AcuityUDRRadmedix, LLC · 2023
  • K231709AcuityDR 1013 G4, AcuityDR 1417 G4, AcuityDR 1717G4Radmedix, LLC · 2023
  • K210919AcuityDReRadmedix, LLC · 2021
  • K201058Accuvue+Radmedix, LLC · 2020
  • K200726AcuityPDRRadmedix, LLC · 2020
  • K193360Acuity SDR Standard, Acuity SDR Plus, Acuity FDR StandardRadmedix, LLC · 2020

All 6 as Radmedix, LLC →