WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

THE TAPE

Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / November 2025 / K250330

510(k) cleared

3mensio Workstation

Pie Medical Imaging BV · Nov 3, 2025 · K250330

FDA cleared the 3mensio Workstation from Pie Medical Imaging BV on Nov 3, 2025 under K250330, a traditional 510(k). The device falls under product code QIH, Automated Radiological Image Processing Software, regulated at 21 CFR 892.2050 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Feb 5, 2025. The decision came 271 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Pie Medical Imaging BV in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K250330?

K250330 is the FDA 510(k) for 3mensio Workstation, submitted by Pie Medical Imaging BV. FDA's decision date was Nov 3, 2025, under product code QIH (Automated Radiological Image Processing Software).

Who makes the 3mensio Workstation?

Pie Medical Imaging BV, based in Maastricht, is the applicant of record for K250330.

How long did the K250330 review take?

FDA received the submission on Feb 5, 2025 and issued its decision on Nov 3, 2025, 271 days later.

← All decisions in November 2025