3mensio Workstation— 510(k) K250330

Substantially Equivalent

Pie Medical Imaging BV

FDA 510(k) clearance K250330 for 3mensio Workstation, Substantially Equivalent on 2025-11-03. Applicant: Pie Medical Imaging BV. Device class: 2.

Clearance details

Applicant: Pie Medical Imaging BV
Product code: Code QIH
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2025-02-05
Decision date: 2025-11-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Maastricht, NL

Download summary PDF View on FDA.gov ↗

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More clearances from Pie Medical Imaging BV

Recalls naming K250330

K-number listed on FDA's recall record

Z-2767-2026 — 3mensio Workstation (Vascular Fenestrated) softwareClass II·Ongoing·PIE Medical Imaging B.V.·20260507

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K250330.

Data sourced from openFDA. This site is unofficial and independent of the FDA.