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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 / K261854

510(k) cleared

xvision Spine system

Augmedics, Ltd. · Jul 31, 2026 · K261854

FDA cleared the xvision Spine system from Augmedics, Ltd. on Jul 31, 2026 under K261854, a traditional 510(k). The device falls under product code SBF, Orthopedic Augmented Reality, regulated at 21 CFR 882.4560 as a Class 2 device. The review panel was Neurology.

FDA logged the submission as received on Jun 3, 2026. The decision came 58 days later, inside the 90 FDA-day goal for a 510(k).

Augmedics, Ltd. has one other decision in the tracker over the last 12 months: K251639 (xvision Spine system).

Questions & Answers

What did FDA clear under K261854?

K261854 is the FDA 510(k) for xvision Spine system, submitted by Augmedics, Ltd.. FDA's decision date was Jul 31, 2026, under product code SBF (Orthopedic Augmented Reality).

Who makes the xvision Spine system?

Augmedics, Ltd., based in Yokneam Illit, is the applicant of record for K261854.

How long did the K261854 review take?

FDA received the submission on Jun 3, 2026 and issued its decision on Jul 31, 2026, 58 days later.

← All decisions in July 2026

Sources