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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 / K251639

510(k) cleared

xvision Spine system

Augmedics, Ltd. · Oct 3, 2025 · K251639

FDA cleared the xvision Spine system from Augmedics, Ltd. on Oct 3, 2025 under K251639, 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 May 29, 2025. The decision came 127 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Augmedics, Ltd. has one other decision in the tracker over the last 12 months: K261854 (xvision Spine system).

Questions & Answers

What did FDA clear under K251639?

K251639 is the FDA 510(k) for xvision Spine system, submitted by Augmedics, Ltd.. FDA's decision date was Oct 3, 2025, 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 K251639.

How long did the K251639 review take?

FDA received the submission on May 29, 2025 and issued its decision on Oct 3, 2025, 127 days later.

← All decisions in October 2025

Sources