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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 / November 2025 / K252328

510(k) cleared

Voluson Expert 18; Voluson Expert 20; Voluson Expert 22

GE Medical Systems Ultrasound and Primary Care Diagnostics · Nov 24, 2025 · K252328

FDA cleared the Voluson Expert 18; Voluson Expert 20; Voluson Expert 22 from GE Medical Systems Ultrasound and Primary Care Diagnostics on Nov 24, 2025 under K252328, a traditional 510(k). The device falls under product code IYN, System, Imaging, Pulsed Doppler, Ultrasonic, regulated at 21 CFR 892.1550 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Jul 25, 2025. The decision came 122 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

GE Medical Systems Ultrasound and Primary Care Diagnostics has 8 other decisions in the tracker over the last 12 months: K261668 (Venue Go), K261835 (LOGIQ Focus), K260398 (LOGIQ e), K260673 (LOGIQ Vita; LOGIQ Vita Pro; LOGIQ Vita Express; LOGIQ Vita Plus; LOGIQ Vita Power; LOGIQ S20; LOGIQ S20 Pro; LOGIQ S20 Express; LOGIQ S20 Plus; LOGIQ S20 Power).

Questions & Answers

What did FDA clear under K252328?

K252328 is the FDA 510(k) for Voluson Expert 18; Voluson Expert 20; Voluson Expert 22, submitted by GE Medical Systems Ultrasound and Primary Care Diagnostics. FDA's decision date was Nov 24, 2025, under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic).

Who makes the Voluson Expert 18; Voluson Expert 20; Voluson Expert 22?

GE Medical Systems Ultrasound and Primary Care Diagnostics, based in Wauwatosa, WI, is the applicant of record for K252328.

How long did the K252328 review take?

FDA received the submission on Jul 25, 2025 and issued its decision on Nov 24, 2025, 122 days later.

← All decisions in November 2025