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FDA 510(k)

3mensio Workstation

K-Number: K250330 · 2025-11-03

Decision Date2025-11-03
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

3mensio Workstation is the device name listed in this FDA 510(k) record. The listed applicant is Pie Medical Imaging BV. It received FDA 510(k) clearance on 2025-11-03 under 510(k) 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. The listed applicant is Pie Medical Imaging BV. The 510(k) number is K250330.

When did 3mensio Workstation receive FDA 510(k) clearance?

3mensio Workstation received FDA 510(k) clearance on 2025-11-03, under 510(k) number K250330.

Who is the listed applicant for 3mensio Workstation?

The FDA 510(k) record lists Pie Medical Imaging BV as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 3mensio Workstation?

The FDA product code for 3mensio Workstation is QIH.

Other records listing Pie Medical Imaging BV as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

View all 10 devices →

Related Devices (Code: QIH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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.