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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 / December 2025 / K251199

510(k) cleared

Allia Moveo

GE Medical Systems SCS · Dec 9, 2025 · K251199

FDA cleared the Allia Moveo from GE Medical Systems SCS on Dec 9, 2025 under K251199, a traditional 510(k). The device falls under product code OWB, Interventional Fluoroscopic X-Ray System, regulated at 21 CFR 892.1650 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Apr 18, 2025. The decision came 235 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

GE Medical Systems SCS has 2 other decisions in the tracker over the last 12 months: K253770 (CardIQ Suite), K260087 (Senographe Pristina; SenoBright HD; Pristina Serena; Pristina Serena Bright).

Questions & Answers

What did FDA clear under K251199?

K251199 is the FDA 510(k) for Allia Moveo, submitted by GE Medical Systems SCS. FDA's decision date was Dec 9, 2025, under product code OWB (Interventional Fluoroscopic X-Ray System).

Who makes the Allia Moveo?

GE Medical Systems SCS, based in Buc, is the applicant of record for K251199.

How long did the K251199 review take?

FDA received the submission on Apr 18, 2025 and issued its decision on Dec 9, 2025, 235 days later.

← All decisions in December 2025

Sources