WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

THE TAPE

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 / K260085

510(k) cleared

RAYMO Mobile X-ray System (Model: RAYMO)

DRGEM Corporation · May 14, 2026 · K260085

FDA cleared the RAYMO Mobile X-ray System (Model: RAYMO) from DRGEM Corporation on May 14, 2026 under K260085, 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 Jan 12, 2026. The decision came 122 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 DRGEM Corporation in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260085?

K260085 is the FDA 510(k) for RAYMO Mobile X-ray System (Model: RAYMO), submitted by DRGEM Corporation. FDA's decision date was May 14, 2026, under product code IZL (System, X-Ray, Mobile).

Who makes the RAYMO Mobile X-ray System (Model: RAYMO)?

DRGEM Corporation, based in Gwangmyeong-Si, is the applicant of record for K260085.

How long did the K260085 review take?

FDA received the submission on Jan 12, 2026 and issued its decision on May 14, 2026, 122 days later.

← All decisions in May 2026