510(k) Report

FDA applicant

Scanditronix Medical AB

Uppsala S-754 50, SE4 decisions1997–20010 recalls

FDA records 4 decisions for Scanditronix Medical AB (Uppsala S-754 50, SE) from 1997 to 2001: 4 510(k) clearances. All are in product code IYE (Accelerator, Linear, Medical). 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, radiology panel, where it files most

How often FDA has decided Scanditronix Medical AB’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Scanditronix Medical AB since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Scanditronix Medical AB 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?

  • IYEAccelerator, Linear, Medical4decisions

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 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.

  • K011763OmnidosScanditronix Medical AB · 20011cites it
  • K961400Rfa-300, Lda UtilityScanditronix Medical AB · 19971cites it

What has FDA decided for it lately?

  • K011763OmnidosScanditronix Medical AB · 2001
  • K002051InvidosScanditronix Medical AB · 2000
  • K990734DPD-12PCCScanditronix Medical AB · 1999
  • K961400Rfa-300, Lda UtilityScanditronix Medical AB · 1997

All 4 as Scanditronix Medical AB →

Other applicant names beginning “Scanditronix”

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

Scanditronix, Inc. 7Scanditronix Wellhofer GmbH 1Scanditronix Wellhofer North America 1