510(k) Report

FDA applicant

Edlen Imaging, LLC

Scottsdale, AZ3 decisions2011–20160 recalls

FDA records 3 decisions for Edlen Imaging, LLC (Scottsdale, AZ) from 2011 to 2016: 3 510(k) clearances. Most are in product codes MUH (System, X-Ray, Extraoral Source, Digital) and OAS (X-Ray, Tomography, Computed, Dental). Its devices cite 6 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, dental panel, where it files most

How often FDA has decided Edlen Imaging, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2016

2011: 12015: 12016: 1
2011high 1 (2011) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2011.

FIG. 1 — Edlen Imaging, LLC by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • MUHSystem, X-Ray, Extraoral Source, Digital2decisions
  • OASX-Ray, Tomography, Computed, Dental1decision

Whose devices does it build on?

Its devices cite 6 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 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.

  • K103290Edlen Imaging - Gemini DusbEdlen Imaging, LLC · 20112cite it
  • K150823EDLENi Intra-Oral SensorEdlen Imaging, LLC · 20152cite it

What has FDA decided for it lately?

  • K151137X-View, ImagenEdlen Imaging, LLC · 2016
  • K150823EDLENi Intra-Oral SensorEdlen Imaging, LLC · 2015
  • K103290Edlen Imaging - Gemini DusbEdlen Imaging, LLC · 2011

All 3 as Edlen Imaging, LLC →