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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 / January 2026 / K253499

510(k) cleared

Ascent3T Neonatal Magnetic Resonance Imaging System

Eyas Medical Imaging, Inc. · Jan 26, 2026 · K253499

FDA cleared the Ascent3T Neonatal Magnetic Resonance Imaging System from Eyas Medical Imaging, Inc. on Jan 26, 2026 under K253499, a traditional 510(k) reviewed through the Third Party Review Program. 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 Oct 29, 2025. The decision came 89 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Eyas Medical Imaging, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253499?

K253499 is the FDA 510(k) for Ascent3T Neonatal Magnetic Resonance Imaging System, submitted by Eyas Medical Imaging, Inc.. FDA's decision date was Jan 26, 2026, under product code LNH (System, Nuclear Magnetic Resonance Imaging).

Who makes the Ascent3T Neonatal Magnetic Resonance Imaging System?

Eyas Medical Imaging, Inc., based in Cincinnati, OH, is the applicant of record for K253499.

How long did the K253499 review take?

FDA received the submission on Oct 29, 2025 and issued its decision on Jan 26, 2026, 89 days later.

← All decisions in January 2026