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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 / February 2026 / K253714

510(k) cleared

IntraSight Plus

Philips Image Guided Therapy Corporation · Feb 24, 2026 · K253714

FDA cleared the IntraSight Plus from Philips Image Guided Therapy Corporation on Feb 24, 2026 under K253714, a traditional 510(k). The device falls under product code IYO, System, Imaging, Pulsed Echo, Ultrasonic, regulated at 21 CFR 892.1560 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Nov 24, 2025. The decision came 92 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Philips Image Guided Therapy Corporation in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253714?

K253714 is the FDA 510(k) for IntraSight Plus, submitted by Philips Image Guided Therapy Corporation. FDA's decision date was Feb 24, 2026, under product code IYO (System, Imaging, Pulsed Echo, Ultrasonic).

Who makes the IntraSight Plus?

Philips Image Guided Therapy Corporation, based in Colorado Springs, CO, is the applicant of record for K253714.

How long did the K253714 review take?

FDA received the submission on Nov 24, 2025 and issued its decision on Feb 24, 2026, 92 days later.

← All decisions in February 2026