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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 / May 2026 / K260716

510(k) cleared

Neowise

Cefla S.C. · May 4, 2026 · K260716

FDA cleared the Neowise from Cefla S.C. on May 4, 2026 under K260716, a traditional 510(k). The device falls under product code LLZ, System, Image Processing, Radiological, regulated at 21 CFR 892.2050 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Mar 5, 2026. The decision came 60 days later, inside the 90 FDA-day goal for a 510(k).

Cefla S.C. has one other decision in the tracker over the last 12 months: K252353 (myray ProXIma X6).

Questions & Answers

What did FDA clear under K260716?

K260716 is the FDA 510(k) for Neowise, submitted by Cefla S.C.. FDA's decision date was May 4, 2026, under product code LLZ (System, Image Processing, Radiological).

Who makes the Neowise?

Cefla S.C., based in Imola (Bo), is the applicant of record for K260716.

How long did the K260716 review take?

FDA received the submission on Mar 5, 2026 and issued its decision on May 4, 2026, 60 days later.

← All decisions in May 2026