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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 / K260338

510(k) cleared

ThinkSono Guidance

ThinkSono GmbH · Jul 15, 2026 · K260338

FDA cleared the ThinkSono Guidance from ThinkSono GmbH on Jul 15, 2026 under K260338, a traditional 510(k). The device falls under product code QJU, Image Acquisition And/Or Optimization Guided By Artificial Intelligence, regulated at 21 CFR 892.2100 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Feb 2, 2026. The decision came 163 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 ThinkSono GmbH in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260338?

K260338 is the FDA 510(k) for ThinkSono Guidance, submitted by ThinkSono GmbH. FDA's decision date was Jul 15, 2026, under product code QJU (Image Acquisition And/Or Optimization Guided By Artificial Intelligence).

Who makes the ThinkSono Guidance?

ThinkSono GmbH, based in Potsdam, is the applicant of record for K260338.

How long did the K260338 review take?

FDA received the submission on Feb 2, 2026 and issued its decision on Jul 15, 2026, 163 days later.

← All decisions in July 2026