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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 / May 2026 / K261132

510(k) cleared

Healium Intelliscan LX192LC

Healium Intelliscan Corporation · May 5, 2026 · K261132

FDA cleared the Healium Intelliscan LX192LC from Healium Intelliscan Corporation on May 5, 2026 under K261132, a special 510(k). The device falls under product code IYN, System, Imaging, Pulsed Doppler, Ultrasonic, regulated at 21 CFR 892.1550 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Apr 6, 2026. The decision came 29 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Healium Intelliscan Corporation in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K261132?

K261132 is the FDA 510(k) for Healium Intelliscan LX192LC, submitted by Healium Intelliscan Corporation. FDA's decision date was May 5, 2026, under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic).

Who makes the Healium Intelliscan LX192LC?

Healium Intelliscan Corporation, based in New York, Ny, NY, is the applicant of record for K261132.

How long did the K261132 review take?

FDA received the submission on Apr 6, 2026 and issued its decision on May 5, 2026, 29 days later.

← All decisions in May 2026