510(k) Report

FDA applicant

Mriguidance B.V.

Utrecht, NL4 decisions2021–20260 recalls

FDA records 4 decisions for Mriguidance B.V. (Utrecht, NL) from 2021 to 2026: 4 510(k) clearances. All are in product code QIH (Automated Radiological Image Processing Software). Since 2016 its 510(k)s took a median of 170 days from receipt to decision, against 136 for FDA’s reviews in the same codes and years. Its devices cite 4 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 Mriguidance B.V.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2021: 12023: 12024: 12026 (partial year): 1
2021high 1 (2021) · low 0 (2022)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2021.

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

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Which product codes does it file in?

  • QIHAutomated Radiological Image Processing Software4decisions

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 170 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 136 days; 1 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 4 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 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.

  • K233030BoneMRIMriguidance B.V. · 20242cite it
  • K230197BoneMRI v1.6Mriguidance B.V. · 20231cites it
  • K202404BoneMRIMriguidance B.V. · 20211cites it

What has FDA decided for it lately?

  • K260584BoneMRIMriguidance B.V. · 2026
  • K233030BoneMRIMriguidance B.V. · 2024
  • K230197BoneMRI v1.6Mriguidance B.V. · 2023
  • K202404BoneMRIMriguidance B.V. · 2021

All 4 as Mriguidance B.V. →