510(k) Report

FDA applicant

Medviso AB

Lund, SE3 decisions2009–20220 recalls

FDA records 3 decisions for Medviso AB (Lund, SE) from 2009 to 2022: 3 510(k) clearances. All are in product code LLZ (System, Image Processing, Radiological). Its devices cite 7 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Medviso”.

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

FDA decisions per year

1in 2022

2009: 12017: 12022: 1
2009high 1 (2009) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2009.

FIG. 1 — Medviso AB by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Medviso AB’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?

  • LLZSystem, Image Processing, Radiological3decisions

Whose devices does it build on?

Its devices cite 7 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 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.

  • K090833SegmentMedviso · 20092cite it
  • K163076Segment CMRMedviso AB · 20172cite it

What has FDA decided for it lately?

  • K211966Segment 3DPrintMedviso AB · 2022
  • K163076Segment CMRMedviso AB · 2017
  • K090833SegmentMedviso · 2009

All 2 as Medviso AB →The one decision as Medviso →