510(k) Report

FDA applicant

Pie Medical Imaging BV

Maastricht, NL24 decisions2001–20252 recalls

FDA records 24 decisions for Pie Medical Imaging BV (Maastricht, NL) from 2001 to 2025: 24 510(k) clearances. Most are in product codes LLZ (System, Image Processing, Radiological) and IZI (System, X-Ray, Angiographic). Since 2016 its 510(k)s took a median of 151 days from receipt to decision, against 105 for FDA’s reviews in the same codes and years. Its devices cite 43 predicates, 22 of them its own earlier devices. 2 recalls are linked to its devices.

FDA’s records also spell it “Pie Medical Imaging”.

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 Pie Medical Imaging BV’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2009: 12010: 12012: 22013: 12014: 12015: 12016: 42018: 22022: 12024: 22025: 1
2007high 4 (2016) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2026

2025: 12026 (partial year): 1
2007high 1 (2025) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Pie Medical Imaging BV by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Pie Medical Imaging BV’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, Radiological18decisions
  • IZISystem, X-Ray, Angiographic3decisions
  • QHAX-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device1decision
  • DQKComputer, Diagnostic, Programmable1decision
  • QIHAutomated Radiological Image Processing Software1decision

How long do its 510(k) reviews take?

Since 2016, its 7 510(k)s took a median of 151 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 105 days; 1 of its 7 were faster than that.

Whose devices does it build on?

Its devices cite 43 predicates; 22 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 46 times; 22 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.

  • K1537363mensio WorkstationPie Medical Imaging BV · 201611cite it
  • K052988CAASPie Medical Imaging BV · 20058cite it
  • K1203673MENSIO WorkstationPie Medical Imaging BV · 20124cite it
  • K180019CAAS WorkstationPie Medical Imaging BV · 20183cite it
  • K063344Caas Qca 3DPie Medical Imaging BV · 20062cite it
  • K162376CAAS MR 4D FlowPie Medical Imaging BV · 20162cite it

What has FDA decided for it lately?

  • K2503303mensio WorkstationPie Medical Imaging BV · 20251 recall
  • K232147CAAS WorkstationPie Medical Imaging BV · 2024
  • K232007CAAS MR SolutionsPie Medical Imaging BV · 2024
  • K212376Caas QardiaPie Medical Imaging BV · 2022
  • K181825CAAS MR SolutionsPie Medical Imaging BV · 2018
  • K180019CAAS WorkstationPie Medical Imaging BV · 2018
  • K162376CAAS MR 4D FlowPie Medical Imaging BV · 2016
  • K162112Caas MRVPie Medical Imaging BV · 2016

All 23 as Pie Medical Imaging BV →The one decision as Pie Medical Imaging →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K2503303mensio Workstation (Vascular Fenestrated) softwareMay 7, 2026Class II
  • K1537363mensio Workstation (Vascular Fenestrated) softwareJul 14, 2025Class II