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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 / K261535

510(k) cleared

Hi-D Imaging 4TAVR

Hi-D Imaging AG · Jul 20, 2026 · K261535

FDA cleared the Hi-D Imaging 4TAVR from Hi-D Imaging AG on Jul 20, 2026 under K261535, 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 May 8, 2026. The decision came 73 days later, inside the 90 FDA-day goal for a 510(k).

Hi-D Imaging AG has one other decision in the tracker over the last 12 months: K253898 (QT Scanner 2000 Model A).

Questions & Answers

What did FDA clear under K261535?

K261535 is the FDA 510(k) for Hi-D Imaging 4TAVR, submitted by Hi-D Imaging AG. FDA's decision date was Jul 20, 2026, under product code QIH (Automated Radiological Image Processing Software).

Who makes the Hi-D Imaging 4TAVR?

Hi-D Imaging AG, based in Winterthur, is the applicant of record for K261535.

How long did the K261535 review take?

FDA received the submission on May 8, 2026 and issued its decision on Jul 20, 2026, 73 days later.

← All decisions in July 2026

Sources