510(k) Report

FDA applicant

Quantib B.V.

Rotterdam, NL11 decisions2016–20260 recalls

FDA records 11 decisions for Quantib B.V. (Rotterdam, NL) from 2016 to 2026: 11 510(k) clearances. Most are in product codes LLZ (System, Image Processing, Radiological) and QIH (Automated Radiological Image Processing Software). Since 2016 its 510(k)s took a median of 73 days from receipt to decision, against 115 for FDA’s reviews in the same codes and years. Its devices cite 12 predicates, 7 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 Quantib B.V.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2016: 12017: 12018: 22020: 22022: 22023: 12025: 12026 (partial year): 1
2016high 2 (2018) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2016.

FIG. 1 — Quantib B.V. by year, 2016–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Quantib B.V.’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, Radiological9decisions
  • QIHAutomated Radiological Image Processing Software1decision
  • QDQRadiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For…1decision

How long do its 510(k) reviews take?

Since 2016, its 11 510(k)s took a median of 73 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 115 days; 9 of its 11 were faster than that.

Whose devices does it build on?

Its devices cite 12 predicates; 7 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 8 times; 7 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.

  • K202501Quantib ProstateQuantib B.V. · 20202cite it
  • K213737Quantib NDQuantib B.V. · 20221cites it
  • K173939Quantib BrainQuantib B.V. · 20181cites it
  • K163013Quantib Brain 1.2Quantib B.V. · 20171cites it
  • K221106Quantib ProstateQuantib B.V. · 20221cites it
  • K153351Quantib Brain 1Quantib B.V. · 20161cites it

What has FDA decided for it lately?

  • K253682DeepHealth ProstateAIQuantib B.V. · 2026
  • K251527Brain WMHQuantib B.V. · 2025
  • K230772Quantib ProstateQuantib B.V. · 2023
  • K221106Quantib ProstateQuantib B.V. · 2022
  • K213737Quantib NDQuantib B.V. · 2022
  • K202501Quantib ProstateQuantib B.V. · 2020
  • K200899Quantib AI NodeQuantib B.V. · 2020
  • K182564Quantib NDQuantib B.V. · 2018

All 11 as Quantib B.V. →