510(k) Report

FDA applicant

Vysioneer, Inc.

Cambridge, MA3 decisions2021–20210 recalls

FDA records 3 decisions for Vysioneer, Inc. (Cambridge, MA) in 2021: 3 510(k) clearances. All are in product code QKB (Radiological Image Processing Software For…). Since 2016 its 510(k)s took a median of 97 days from receipt to decision, against 120 for FDA’s reviews in the same codes and years. Its devices cite 5 predicates, 2 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 Vysioneer, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

3in 2021

2021: 3
2021high 3 (2021) · low 0 (2022)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2021.

FIG. 1 — Vysioneer, Inc. by year, 2021–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Vysioneer, Inc.’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?

  • QKBRadiological Image Processing Software For Radiation Therapy3decisions

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 97 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 120 days; 2 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 5 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 times; 2 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.

  • K203235VBrainVysioneer, Inc. · 20214cite it
  • K212116VBrain-OARVysioneer, Inc. · 20211cites it

What has FDA decided for it lately?

  • K213628VBrainVysioneer, Inc. · 2021
  • K212116VBrain-OARVysioneer, Inc. · 2021
  • K203235VBrainVysioneer, Inc. · 2021

All 3 as Vysioneer, Inc. →