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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 / K260607

510(k) cleared

Shield System (Siemens 30x40)

Radiaction , Ltd. · Jul 31, 2026 · K260607

FDA cleared the Shield System (Siemens 30x40) from Radiaction , Ltd. on Jul 31, 2026 under K260607, a special 510(k). The device falls under product code OWB, Interventional Fluoroscopic X-Ray System, regulated at 21 CFR 892.1650 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Feb 24, 2026. The decision came 157 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 Radiaction , Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260607?

K260607 is the FDA 510(k) for Shield System (Siemens 30x40), submitted by Radiaction , Ltd.. FDA's decision date was Jul 31, 2026, under product code OWB (Interventional Fluoroscopic X-Ray System).

Who makes the Shield System (Siemens 30x40)?

Radiaction , Ltd., based in Tel Aviv, is the applicant of record for K260607.

How long did the K260607 review take?

FDA received the submission on Feb 24, 2026 and issued its decision on Jul 31, 2026, 157 days later.

← All decisions in July 2026