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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 / K253595

510(k) cleared

EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System

Philips Ultrasound, LLC · Mar 27, 2026 · K253595

FDA cleared the EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System from Philips Ultrasound, LLC on Mar 27, 2026 under K253595, 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 Nov 18, 2025. The decision came 129 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), 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).

Questions & Answers

What did FDA clear under K253595?

K253595 is the FDA 510(k) for EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System, submitted by Philips Ultrasound, LLC. FDA's decision date was Mar 27, 2026, under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic).

Who makes the EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System?

Philips Ultrasound, LLC, based in Bothell, WA, is the applicant of record for K253595.

How long did the K253595 review take?

FDA received the submission on Nov 18, 2025 and issued its decision on Mar 27, 2026, 129 days later.

← All decisions in March 2026