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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 / March 2026 / K254161

510(k) cleared

Automated Aortic Stenosis Software (AutoAS)

GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · Mar 27, 2026 · K254161

FDA cleared the Automated Aortic Stenosis Software (AutoAS) from GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC on Mar 27, 2026 under K254161, a traditional 510(k). The device falls under product code POK, Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer, regulated at 21 CFR 892.2060 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Dec 22, 2025. The decision came 95 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC has one other decision in the tracker over the last 12 months: K252718 (Lunar Astra).

Questions & Answers

What did FDA clear under K254161?

K254161 is the FDA 510(k) for Automated Aortic Stenosis Software (AutoAS), submitted by GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC. FDA's decision date was Mar 27, 2026, under product code POK (Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer).

Who makes the Automated Aortic Stenosis Software (AutoAS)?

GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC, based in Waukesha, WI, is the applicant of record for K254161.

How long did the K254161 review take?

FDA received the submission on Dec 22, 2025 and issued its decision on Mar 27, 2026, 95 days later.

← All decisions in March 2026

Sources