3mensio Workstation
FDA 510(k) K250330 · Pie Medical Imaging BV
510(k) numberK250330
Submission
- Device name
- 3mensio Workstation
- Applicant
- Pie Medical Imaging BV
Maastricht, NL - Received
- February 5, 2025
- Decision date
- November 3, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QIH – Automated Radiological Image Processing Software
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 892.2050
- Specialty
- Radiology
To provide automated radiological image processing and analysis tools. Software implementing artificial intelligence including nonadaptive machine learning algorithms trained with clinical and/or artificial data. In these devices, the algorithm training data typically impacts device performance. Adaptive AI algorithms are not within scope of this product code.
Other 510(k)s with product code QIH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261795 | Quicktome Software SuiteQIH · Traditional | Omniscient Neurotechnology Pty, Ltd. | 09/10/2026SE |
| K260879 | 4DMQIH · Traditional | Invia, LLC | 09/10/2026SE |
| K251417 | ReVISION 2QIH · Traditional | Argus Cognitive, Inc. | 09/09/2026SE |
| K260525 | NextMR SpineQIH · Traditional | MRI2CT, Inc. | 09/04/2026SE |
| K260811 | Heartvue.ProtonQIH · Traditional | Heartvue.ai, Inc. | 08/26/2026SE |
| K261595 | Ceevra Reveal 4QIH · Traditional | Ceevra, Inc. | 08/25/2026SE |
| K262127 | DS Core CBCT AnatomyQIH · Traditional | Dentsply Sirona | 08/21/2026SE |
| K260584 | BoneMRIQIH · Traditional | Mriguidance B.V. | 08/21/2026SE |
| K261641 | Lower Limb AI (LLAI)QIH · Traditional | AI Planning Logic, Inc. | 08/18/2026SE |
| K253794 | Prostate CoreQIH · Traditional | Lucida Medical, Ltd. | 08/10/2026SE |
More from Lucida Medical, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K232147 | CAAS WorkstationQHA · Traditional | 04/09/2024SE |
| K232007 | CAAS MR SolutionsLLZ · Traditional | 02/01/2024SE |
| K212376 | Caas QardiaLLZ · Traditional | 05/16/2022SE |
| K181825 | CAAS MR SolutionsLLZ · Traditional | 12/04/2018SE |
| K180019 | CAAS WorkstationIZI · Traditional | 05/03/2018SE |
| K162376 | CAAS MR 4D FlowLLZ · Traditional | 12/08/2016SE |
| K162112 | Caas MRVLLZ · Traditional | 09/21/2016SE |
| K153736 | 3mensio WorkstationLLZ · Traditional | 05/27/2016SE |
| K151780 | CAAS WorkstationIZI · Traditional | 03/11/2016SE |
| K143044 | CAAS A-ValveLLZ · Traditional | 02/06/2015SE |
Questions and answers
When was 3mensio Workstation cleared by the FDA?
3mensio Workstation (K250330) received a 510(k) decision of Substantially Equivalent on November 3, 2025, 271 days after the submission was received.
What is the product code of K250330?
The FDA product code is QIH – Automated Radiological Image Processing Software, a Class II (moderate risk) device regulated under 21 CFR 892.2050.