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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 / K251673

510(k) cleared

X9 Ultrasound System

X9, Inc. · Oct 17, 2025 · K251673

FDA cleared the X9 Ultrasound System from X9, Inc. on Oct 17, 2025 under K251673, a traditional 510(k). The device falls under product code SGH, Ultrasound Imaging For Vascular Access For Hemodialysis, regulated at 21 CFR 892.1560 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on May 30, 2025. The decision came 140 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

X9, Inc. has 8 other decisions in the tracker over the last 12 months: K253808 (AIR Recon DL), K253667 (Accoat Guide Wire), K254130 (C.A. Medical Interbody Fusion System), K253317 (Cytrans Elashield).

Questions & Answers

What did FDA clear under K251673?

K251673 is the FDA 510(k) for X9 Ultrasound System, submitted by X9, Inc.. FDA's decision date was Oct 17, 2025, under product code SGH (Ultrasound Imaging For Vascular Access For Hemodialysis).

Who makes the X9 Ultrasound System?

X9, Inc., based in Wallingford, CT, is the applicant of record for K251673.

How long did the K251673 review take?

FDA received the submission on May 30, 2025 and issued its decision on Oct 17, 2025, 140 days later.

← All decisions in October 2025