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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 / December 2025 / K253489

510(k) cleared

Swoop® Portable MR Imaging® System

Hyperfine, Inc. · Dec 12, 2025 · K253489

FDA cleared the Swoop® Portable MR Imaging® System from Hyperfine, Inc. on Dec 12, 2025 under K253489, a special 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 Oct 24, 2025. The decision came 49 days later, inside the 90 FDA-day goal for a 510(k).

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

Questions & Answers

What did FDA clear under K253489?

K253489 is the FDA 510(k) for Swoop® Portable MR Imaging® System, submitted by Hyperfine, Inc.. FDA's decision date was Dec 12, 2025, under product code LNH (System, Nuclear Magnetic Resonance Imaging).

Who makes the Swoop® Portable MR Imaging® System?

Hyperfine, Inc., based in Guilforf, CT, is the applicant of record for K253489.

How long did the K253489 review take?

FDA received the submission on Oct 24, 2025 and issued its decision on Dec 12, 2025, 49 days later.

← All decisions in December 2025