510(k) Report

FDA applicant

Dyn'R Sas

Aix En Provence, FR2 decisions2010–20120 recalls

FDA records 2 decisions for Dyn'R Sas (Aix En Provence, FR) from 2010 to 2012: 2 510(k) clearances. All are in product code IYE (Accelerator, Linear, Medical). Its devices cite 3 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Dyn'R”.

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 Dyn'R Sas’s devices, and how often a recall has named them.

FDA decisions per year

1in 2012

2010: 12012: 1
2010high 1 (2010) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2010.

FIG. 1 — Dyn'R Sas by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Dyn'R Sas’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • IYEAccelerator, Linear, Medical2decisions

Whose devices does it build on?

Its devices cite 3 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K092479SDX-Spirodynr'x Radiotherapy Breathing ControlDyn'R · 20101cites it

What has FDA decided for it lately?

  • K121845SDX SystemDyn'R Sas · 2012
  • K092479SDX-Spirodynr'x Radiotherapy Breathing ControlDyn'R · 2010

The one decision as Dyn'R Sas →The one decision as Dyn'R →