510(k) Report

FDA applicant

Stephanix Radiological Systems

Naples, FL1 decision2010–20101 recall

FDA records 1 decision for Stephanix Radiological Systems (Naples, FL) in 2010: 1 510(k) clearance. All are in product code OWB (Interventional Fluoroscopic X-Ray System). Its devices cite 1 predicate, 0 of them its own earlier devices. 1 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 Stephanix Radiological Systems’s devices, and how often a recall has named them.

FDA decisions per year

1in 2010

2010: 1
2010high 1 (2010) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

1in 2018

2018: 1
2010high 1 (2018) · low 0 (2010)2026

Class I Class II/III not classified

FIG. 1 — Stephanix Radiological Systems by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • OWBInterventional Fluoroscopic X-Ray System1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 0 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.

  • K102529D2RF Digital Dynamic Remote SystemStephanix Radiological Systems · 20102cite it

What has FDA decided for it lately?

  • K102529D2RF Digital Dynamic Remote SystemStephanix Radiological Systems · 20101 recall

The one decision as Stephanix Radiological Systems →

What has been recalled?

1 recall linked to its devices; the latest:

  • K102529STEPHANIX D2RS Digital Dynamic Remote…Nov 2, 2018Class II

Other applicant names beginning “Stephanix”

FDA records each applicant name separately; these may or may not be the same firm.

Stephanix 3Stephanix Radiological Solutions 1