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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 / March 2026 / K254277

510(k) cleared

Embrace Neonatal MRI System

Aspect Imaging, Ltd. · Mar 13, 2026 · K254277

FDA cleared the Embrace Neonatal MRI System from Aspect Imaging, Ltd. on Mar 13, 2026 under K254277, a traditional 510(k). The device falls under product code LNH, System, Nuclear Magnetic Resonance Imaging, regulated at 21 CFR 892.1000 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Dec 30, 2025. The decision came 73 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Aspect Imaging, Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K254277?

K254277 is the FDA 510(k) for Embrace Neonatal MRI System, submitted by Aspect Imaging, Ltd.. FDA's decision date was Mar 13, 2026, under product code LNH (System, Nuclear Magnetic Resonance Imaging).

Who makes the Embrace Neonatal MRI System?

Aspect Imaging, Ltd., based in Shoham, is the applicant of record for K254277.

How long did the K254277 review take?

FDA received the submission on Dec 30, 2025 and issued its decision on Mar 13, 2026, 73 days later.

← All decisions in March 2026