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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 / April 2026 / K252718

510(k) cleared

Lunar Astra

GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · Apr 20, 2026 · K252718

FDA cleared the Lunar Astra from GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC on Apr 20, 2026 under K252718, a traditional 510(k). The device falls under product code KGI, Densitometer, Bone, regulated at 21 CFR 892.1170 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Aug 28, 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 Ultrasound & Primary Care Diagnostics, LLC has one other decision in the tracker over the last 12 months: K254161 (Automated Aortic Stenosis Software (AutoAS)).

Questions & Answers

What did FDA clear under K252718?

K252718 is the FDA 510(k) for Lunar Astra, submitted by GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC. FDA's decision date was Apr 20, 2026, under product code KGI (Densitometer, Bone).

Who makes the Lunar Astra?

GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC, based in Madison, WI, is the applicant of record for K252718.

How long did the K252718 review take?

FDA received the submission on Aug 28, 2025 and issued its decision on Apr 20, 2026, 235 days later.

← All decisions in April 2026

Sources