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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 / K254265

510(k) cleared

Helion Viewer Suite

Videomed Srl ( a Baxter Healthcare Corp company) · May 27, 2026 · K254265

FDA cleared the Helion Viewer Suite from Videomed Srl ( a Baxter Healthcare Corp company) on May 27, 2026 under K254265, 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 Dec 30, 2025. The decision came 148 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 Videomed Srl ( a Baxter Healthcare Corp company) in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K254265?

K254265 is the FDA 510(k) for Helion Viewer Suite, submitted by Videomed Srl ( a Baxter Healthcare Corp company). FDA's decision date was May 27, 2026, under product code LLZ (System, Image Processing, Radiological).

Who makes the Helion Viewer Suite?

Videomed Srl ( a Baxter Healthcare Corp company), based in Limena (Pd), is the applicant of record for K254265.

How long did the K254265 review take?

FDA received the submission on Dec 30, 2025 and issued its decision on May 27, 2026, 148 days later.

← All decisions in May 2026