510(k) Report

FDA applicant

Mvision AI OY

Helsinki, FI3 decisions2022–20250 recalls

FDA records 3 decisions for Mvision AI OY (Helsinki, FI) from 2022 to 2025: 3 510(k) clearances. Most are in product codes QKB (Radiological Image Processing Software For…) and MUJ (System, Planning, Radiation Therapy Treatment). Since 2016 its 510(k)s took a median of 232 days from receipt to decision, against 173 for FDA’s reviews in the same codes and years. 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 “MVision AI”.

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 Mvision AI OY’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2022: 12024: 12025: 1
2022high 1 (2022) · low 0 (2023)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2022.

FIG. 1 — Mvision AI OY by year, 2022–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • QKBRadiological Image Processing Software For Radiation Therapy2decisions
  • MUJSystem, Planning, Radiation Therapy Treatment1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 232 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 173 days; 1 of its 3 were faster than that.

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.

  • K212915MVision AI SegmentationMVision AI · 20221cites it

What has FDA decided for it lately?

  • K250064Dose+ (1.0)Mvision AI OY · 2025
  • K241490Contour+ (MVision AI Segmentation)Mvision AI OY · 2024
  • K212915MVision AI SegmentationMVision AI · 2022

All 2 as Mvision AI OY →The one decision as MVision AI →