510(k) Report

FDA applicant

Owandy

Ormond Beach, FL7 decisions2006–20141 recall

FDA records 7 decisions for Owandy (Ormond Beach, FL) from 2006 to 2014: 7 510(k) clearances. Most are in product codes MUH (System, X-Ray, Extraoral Source, Digital) and OAS (X-Ray, Tomography, Computed, Dental). Its devices cite 10 predicates, 3 of them its own earlier devices. 1 recall is linked to its devices.

FDA’s records also spell it “Owandy Sas”.

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 Owandy’s devices, and how often a recall has named them.

FDA decisions per year

1in 2014

2007: 12009: 12010: 12013: 12014: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

1in 2015

2015: 1
2007high 1 (2015) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Owandy by year, 2007–2026Sources: 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, Digital5decisions
  • OASX-Ray, Tomography, Computed, Dental1decision
  • EHDUnit, X-Ray, Extraoral With Timer1decision

Whose devices does it build on?

Its devices cite 10 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 7 times; 3 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.

  • K053172Universal-X (Usa) or /Krystal-X (Europe)Owandy Sas · 20062cite it
  • K130443I-Max Touch 3DOwandy · 20131cites it
  • K070505Krystal-X WifiOwandy · 20071cites it
  • K062403Imax Ceph Digital X-Ray SensorOwandy · 20061cites it
  • K093105VisteoOwandy · 20101cites it
  • K133271Opteo, Videograph HDOwandy · 20141cites it

What has FDA decided for it lately?

  • K133271Opteo, Videograph HDOwandy · 2014
  • K130443I-Max Touch 3DOwandy · 20131 recall
  • K093105VisteoOwandy · 2010
  • K083057I-Max TouchOwandy · 2009
  • K070505Krystal-X WifiOwandy · 2007
  • K062403Imax Ceph Digital X-Ray SensorOwandy · 2006
  • K053172Universal-X (Usa) or /Krystal-X (Europe)Owandy Sas · 2006

All 6 as Owandy →The one decision as Owandy Sas →

What has been recalled?

1 recall linked to its devices; the latest:

  • K130443Owandy Radiology I -MAX Touch 3D X-rayAug 5, 2015Class II