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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 / July 2026 / K261211

510(k) cleared

Philips EPIQ Series Diagnostic Ultrasound System; Philips Affiniti Series Diagnostic Ultrasound System

Philips Ultrasound, LLC · Jul 27, 2026 · K261211

FDA cleared the Philips EPIQ Series Diagnostic Ultrasound System; Philips Affiniti Series Diagnostic Ultrasound System from Philips Ultrasound, LLC on Jul 27, 2026 under K261211, 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 Apr 14, 2026. The decision came 104 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Philips Ultrasound, LLC has 8 other decisions in the tracker over the last 12 months: K262311 (Alturion 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 K261211?

K261211 is the FDA 510(k) for Philips EPIQ Series Diagnostic Ultrasound System; Philips Affiniti Series Diagnostic Ultrasound System, submitted by Philips Ultrasound, LLC. FDA's decision date was Jul 27, 2026, under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic).

Who makes the Philips EPIQ Series Diagnostic Ultrasound System; Philips Affiniti Series Diagnostic Ultrasound System?

Philips Ultrasound, LLC, based in Bothell, WA, is the applicant of record for K261211.

How long did the K261211 review take?

FDA received the submission on Apr 14, 2026 and issued its decision on Jul 27, 2026, 104 days later.

← All decisions in July 2026