510(k) Report

FDA applicant

Screenpoint Medical B.V.

Nijmegen, NL8 decisions2018–20260 recalls

FDA records 8 decisions for Screenpoint Medical B.V. (Nijmegen, NL) from 2018 to 2026: 8 510(k) clearances. Most are in product codes QDQ (Radiological Computer Assisted…) and QIH (Automated Radiological Image Processing Software). Since 2016 its 510(k)s took a median of 131 days from receipt to decision, against 154 for FDA’s reviews in the same codes and years. Its devices cite 8 predicates, 6 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 Screenpoint Medical B.V.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2018: 12019: 12020: 12021: 12022: 12023: 12024: 12026 (partial year): 1
2018high 1 (2018) · low 0 (2025)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2018.

FIG. 1 — Screenpoint Medical B.V. by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Screenpoint Medical 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?

  • QDQRadiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For…7decisions
  • QIHAutomated Radiological Image Processing Software1decision

How long do its 510(k) reviews take?

Since 2016, its 6 510(k)s took a median of 131 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 154 days; 4 of its 6 were faster than that.

Whose devices does it build on?

Its devices cite 8 predicates; 6 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 14 times; 6 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.

  • K181704TransparaScreenpoint Medical B.V. · 20186cite it
  • K193229TransparaScreenpoint Medical B.V. · 20202cite it
  • K241831Transpara (2.1.0)Screenpoint Medical B.V. · 20242cite it
  • K221347Transpara 1.7.2Screenpoint Medical B.V. · 20222cite it
  • K210404Transpara 1.7.0Screenpoint Medical B.V. · 20211cites it
  • K192287TransparaScreenpoint Medical B.V. · 20191cites it

What has FDA decided for it lately?

  • K260898Transpara (2.1.0)Screenpoint Medical B.V. · 2026
  • K241831Transpara (2.1.0)Screenpoint Medical B.V. · 2024
  • K232096Transpara Density 1.0.0Screenpoint Medical B.V. · 2023
  • K221347Transpara 1.7.2Screenpoint Medical B.V. · 2022
  • K210404Transpara 1.7.0Screenpoint Medical B.V. · 2021
  • K193229TransparaScreenpoint Medical B.V. · 2020
  • K192287TransparaScreenpoint Medical B.V. · 2019
  • K181704TransparaScreenpoint Medical B.V. · 2018

All 8 as Screenpoint Medical B.V. →