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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 / K251937

510(k) cleared

nordicAudio (1.0)

Nordicneurolab AS · Mar 20, 2026 · K251937

FDA cleared the nordicAudio (1.0) from Nordicneurolab AS on Mar 20, 2026 under K251937, 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 Jun 24, 2025. The decision came 269 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Nordicneurolab AS in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251937?

K251937 is the FDA 510(k) for nordicAudio (1.0), submitted by Nordicneurolab AS. FDA's decision date was Mar 20, 2026, under product code LNH (System, Nuclear Magnetic Resonance Imaging).

Who makes the nordicAudio (1.0)?

Nordicneurolab AS, based in Bergen, is the applicant of record for K251937.

How long did the K251937 review take?

FDA received the submission on Jun 24, 2025 and issued its decision on Mar 20, 2026, 269 days later.

← All decisions in March 2026