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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 / December 2025 / K251763

510(k) cleared

IRISeg

Intuitive Surgical, Inc. · Dec 16, 2025 · K251763

FDA cleared the IRISeg from Intuitive Surgical, Inc. on Dec 16, 2025 under K251763, a traditional 510(k). The device falls under product code QIH, Automated Radiological Image Processing Software, regulated at 21 CFR 892.2050 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Jun 9, 2025. The decision came 190 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Intuitive Surgical, Inc. has 8 other decisions in the tracker over the last 12 months: K253702 (Intuitive Endoluminal Gastrointestinal System (IG1000)), K261824 (da Vinci Surgical System, Model IS5000), K261249 (Universal Seal (5-12 mm)), K260695 (da Vinci Firefly Imaging System).

Questions & Answers

What did FDA clear under K251763?

K251763 is the FDA 510(k) for IRISeg, submitted by Intuitive Surgical, Inc.. FDA's decision date was Dec 16, 2025, under product code QIH (Automated Radiological Image Processing Software).

Who makes the IRISeg?

Intuitive Surgical, Inc., based in Sunnyvale, CA, is the applicant of record for K251763.

How long did the K251763 review take?

FDA received the submission on Jun 9, 2025 and issued its decision on Dec 16, 2025, 190 days later.

← All decisions in December 2025