3mensio Workstation— 510(k) K153736

Name: FDA 510(k) clearance K153736
Creator: U.S. Food and Drug Administration
Published: 2016-05-27

Substantially Equivalent

Pie Medical Imaging BV

FDA 510(k) clearance K153736 for 3mensio Workstation, Substantially Equivalent on 2016-05-27. Applicant: Pie Medical Imaging BV. Device class: 2.

Clearance details

Applicant: Pie Medical Imaging BV
Product code: Code LLZ
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2015-12-28
Decision date: 2016-05-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Maastricht, NL

Download summary PDF View on FDA.gov ↗

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Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K153736

K-number listed on FDA's recall record

Z-2297-2025 — 3mensio Workstation (Vascular Fenestrated) softwareClass II·Ongoing·PIE Medical Imaging B.V.·20250714

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K153736.

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