510(k) Report

FDA applicant

Swissray Medical AG

East Brunswick, NJ4 decisions2005–20132 recalls

FDA records 4 decisions for Swissray Medical AG (East Brunswick, NJ) from 2005 to 2013: 4 510(k) clearances. Most are in product codes KPR (System, X-Ray, Stationary) and MQB (Solid State X-Ray Imager (Flat Panel/Digital…). Its devices cite 4 predicates, 1 of them its own earlier devices. 2 recalls are 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 Swissray Medical AG’s devices, and how often a recall has named them.

FDA decisions per year

1in 2013

2011: 12012: 12013: 1
2007high 1 (2011) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

2in 2016

2016: 2
2007high 2 (2016) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Swissray Medical AG 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?

  • KPRSystem, X-Ray, Stationary2decisions
  • MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)2decisions

Whose devices does it build on?

Its devices cite 4 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 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.

  • K110828DdrelementSwissray Medical AG · 20111cites it
  • K123005Ddrversa MotionSwissray Medical AG · 20121cites it

What has FDA decided for it lately?

  • K131314Ddrcruze (Digital Mobile Diagnostic X-Ray System)Swissray Medical AG · 2013
  • K123005Ddrversa MotionSwissray Medical AG · 2012
  • K110828DdrelementSwissray Medical AG · 2011
  • K052943Ddrformula and Ddrformula PlusSwissray Medical AG · 20052 recalls

All 4 as Swissray Medical AG →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K052943ddR Formula B X-ray System, Model ddR Formula B X-ray system used for imagingNov 18, 2016Class II
  • K052943ddR Formula B X-ray System, ddR Formula B Product Usage: X-ray system used for imagingAug 9, 2016Class II

Other applicant names beginning “Swissray”

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

Swissray Finatech, Inc. 3Swissray International, Inc. 3Swissray Teleray AG 1