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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 / October 2025 / K252476

510(k) cleared

Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart Layout

Brainlab AG · Oct 16, 2025 · K252476

FDA cleared the Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart Layout from Brainlab AG on Oct 16, 2025 under K252476, a special 510(k). The device falls under product code LLZ, System, Image Processing, Radiological, regulated at 21 CFR 892.2050 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Aug 7, 2025. The decision came 70 days later, inside the 90 FDA-day goal for a 510(k).

Brainlab AG has 2 other decisions in the tracker over the last 12 months: K254010 (ExacTrac Dynamic (2.0.2); ExacTrac Dynamic Surface), K252562 (Spine & Trauma Navigation Instruments).

Questions & Answers

What did FDA clear under K252476?

K252476 is the FDA 510(k) for Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart Layout, submitted by Brainlab AG. FDA's decision date was Oct 16, 2025, under product code LLZ (System, Image Processing, Radiological).

Who makes the Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart Layout?

Brainlab AG, based in Munich, is the applicant of record for K252476.

How long did the K252476 review take?

FDA received the submission on Aug 7, 2025 and issued its decision on Oct 16, 2025, 70 days later.

← All decisions in October 2025

Sources