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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 / K260217

510(k) cleared

AI Platform 2.2 (AIP002)

Exo Imaging · Feb 24, 2026 · K260217

FDA cleared the AI Platform 2.2 (AIP002) from Exo Imaging on Feb 24, 2026 under K260217, a special 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 Jan 23, 2026. The decision came 32 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Exo Imaging in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260217?

K260217 is the FDA 510(k) for AI Platform 2.2 (AIP002), submitted by Exo Imaging. FDA's decision date was Feb 24, 2026, under product code QIH (Automated Radiological Image Processing Software).

Who makes the AI Platform 2.2 (AIP002)?

Exo Imaging, based in Santa Clara, CA, is the applicant of record for K260217.

How long did the K260217 review take?

FDA received the submission on Jan 23, 2026 and issued its decision on Feb 24, 2026, 32 days later.

← All decisions in February 2026