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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 / K253103

510(k) cleared

Nexus DRF Digital X-ray Imaging System

Varex Imaging Corporation · May 29, 2026 · K253103

FDA cleared the Nexus DRF Digital X-ray Imaging System from Varex Imaging Corporation on May 29, 2026 under K253103, a traditional 510(k). The device falls under product code JAA, System, X-Ray, Fluoroscopic, Image-Intensified, regulated at 21 CFR 892.1650 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Sep 24, 2025. The decision came 247 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 Varex Imaging Corporation in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253103?

K253103 is the FDA 510(k) for Nexus DRF Digital X-ray Imaging System, submitted by Varex Imaging Corporation. FDA's decision date was May 29, 2026, under product code JAA (System, X-Ray, Fluoroscopic, Image-Intensified).

Who makes the Nexus DRF Digital X-ray Imaging System?

Varex Imaging Corporation, based in Salt Lake City, UT, is the applicant of record for K253103.

How long did the K253103 review take?

FDA received the submission on Sep 24, 2025 and issued its decision on May 29, 2026, 247 days later.

← All decisions in May 2026