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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 / March 2026 / K253185

510(k) cleared

Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray System

Carestream Health · Mar 11, 2026 · K253185

FDA cleared the Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray System from Carestream Health on Mar 11, 2026 under K253185, a traditional 510(k). The device falls under product code IZL, System, X-Ray, Mobile, regulated at 21 CFR 892.1720 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Sep 26, 2025. The decision came 166 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Carestream Health has one other decision in the tracker over the last 12 months: K250954 (DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector, Lux HD 43 detector).

Questions & Answers

What did FDA clear under K253185?

K253185 is the FDA 510(k) for Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray System, submitted by Carestream Health. FDA's decision date was Mar 11, 2026, under product code IZL (System, X-Ray, Mobile).

Who makes the Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray System?

Carestream Health, based in Rochester, NY, is the applicant of record for K253185.

How long did the K253185 review take?

FDA received the submission on Sep 26, 2025 and issued its decision on Mar 11, 2026, 166 days later.

← All decisions in March 2026

Sources