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.

Clearance details

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

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