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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 / August 2026 / K261668

510(k) cleared

Venue Go

GE Medical Systems Ultrasound and Primary care Diagnostics, LLC · Aug 7, 2026 · K261668

FDA cleared the Venue Go from GE Medical Systems Ultrasound and Primary care Diagnostics, LLC on Aug 7, 2026 under K261668, a traditional 510(k). The device falls under product code IYN, System, Imaging, Pulsed Doppler, Ultrasonic, regulated at 21 CFR 892.1550 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on May 20, 2026. The decision came 79 days later, inside the 90 FDA-day goal for a 510(k).

GE Medical Systems Ultrasound and Primary care Diagnostics, LLC has 8 other decisions in the tracker over the last 12 months: K261835 (LOGIQ Focus), K260398 (LOGIQ e), K260673 (LOGIQ Vita; LOGIQ Vita Pro; LOGIQ Vita Express; LOGIQ Vita Plus; LOGIQ Vita Power; LOGIQ S20; LOGIQ S20 Pro; LOGIQ S20 Express; LOGIQ S20 Plus; LOGIQ S20 Power), K253370 (LOGIQ Totus).

Questions & Answers

What did FDA clear under K261668?

K261668 is the FDA 510(k) for Venue Go, submitted by GE Medical Systems Ultrasound and Primary care Diagnostics, LLC. FDA's decision date was Aug 7, 2026, under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic).

Who makes the Venue Go?

GE Medical Systems Ultrasound and Primary care Diagnostics, LLC, based in Waukesha, WI, is the applicant of record for K261668.

How long did the K261668 review take?

FDA received the submission on May 20, 2026 and issued its decision on Aug 7, 2026, 79 days later.

← All decisions in August 2026