3mensio Workstation
K-Number: K250330 · 2025-11-03
ApplicantPie Medical Imaging BV
Decision Date2025-11-03
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
3mensio Workstation is a medical device manufactured by Pie Medical Imaging BV. It received FDA 510(k) clearance on 2025-11-03 under approval number K250330. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the 3mensio Workstation?
3mensio Workstation is a medical device that received FDA 510(k) clearance on 2025-11-03. It is manufactured by Pie Medical Imaging BV. The 510(k) number is K250330.
When was 3mensio Workstation approved by the FDA?
3mensio Workstation received FDA 510(k) clearance on 2025-11-03, under approval number K250330.
What company makes 3mensio Workstation?
3mensio Workstation is manufactured by Pie Medical Imaging BV.
What is the FDA product code for 3mensio Workstation?
The FDA product code for 3mensio Workstation is QIH.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.