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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 / July 2026 / K253450

510(k) cleared

BodyTom Elite (NL4000)

NeuroLogica Corp., a Samsung Company · Jul 28, 2026 · K253450

FDA cleared the BodyTom Elite (NL4000) from NeuroLogica Corp., a Samsung Company on Jul 28, 2026 under K253450, a traditional 510(k). The device falls under product code JAK, System, X-Ray, Tomography, Computed, regulated at 21 CFR 892.1750 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Oct 2, 2025. The decision came 299 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 NeuroLogica Corp., a Samsung Company in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253450?

K253450 is the FDA 510(k) for BodyTom Elite (NL4000), submitted by NeuroLogica Corp., a Samsung Company. FDA's decision date was Jul 28, 2026, under product code JAK (System, X-Ray, Tomography, Computed).

Who makes the BodyTom Elite (NL4000)?

NeuroLogica Corp., a Samsung Company, based in Danvers, MA, is the applicant of record for K253450.

How long did the K253450 review take?

FDA received the submission on Oct 2, 2025 and issued its decision on Jul 28, 2026, 299 days later.

← All decisions in July 2026