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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 / K262311

510(k) cleared

Alturion Series Diagnostic Ultrasound System

Philips Ultrasound, LLC · Aug 4, 2026 · K262311

FDA cleared the Alturion Series Diagnostic Ultrasound System from Philips Ultrasound, LLC on Aug 4, 2026 under K262311, a special 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 Jul 8, 2026. The decision came 27 days later, inside the 90 FDA-day goal for a 510(k).

Philips Ultrasound, LLC has 8 other decisions in the tracker over the last 12 months: K261211 (Philips EPIQ Series Diagnostic Ultrasound System; Philips Affiniti Series Diagnostic Ultrasound System), K260667 (Alturion Series Diagnostic Ultrasound System), K260123 (EPIQ Series Diagnostic Ultrasound System), K260680 (EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems).

Questions & Answers

What did FDA clear under K262311?

K262311 is the FDA 510(k) for Alturion Series Diagnostic Ultrasound System, submitted by Philips Ultrasound, LLC. FDA's decision date was Aug 4, 2026, under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic).

Who makes the Alturion Series Diagnostic Ultrasound System?

Philips Ultrasound, LLC, based in Bothell, WA, is the applicant of record for K262311.

How long did the K262311 review take?

FDA received the submission on Jul 8, 2026 and issued its decision on Aug 4, 2026, 27 days later.

← All decisions in August 2026