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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 / September 2025 / K251650

510(k) cleared

Insight Enhanced DRF (EN-1002-01)

Imaging Engineering, LLC · Sep 16, 2025 · K251650

FDA cleared the Insight Enhanced DRF (EN-1002-01) from Imaging Engineering, LLC on Sep 16, 2025 under K251650, 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 May 29, 2025. The decision came 110 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 Imaging Engineering, LLC in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251650?

K251650 is the FDA 510(k) for Insight Enhanced DRF (EN-1002-01), submitted by Imaging Engineering, LLC. FDA's decision date was Sep 16, 2025, under product code JAA (System, X-Ray, Fluoroscopic, Image-Intensified).

Who makes the Insight Enhanced DRF (EN-1002-01)?

Imaging Engineering, LLC, based in Gainesville, FL, is the applicant of record for K251650.

How long did the K251650 review take?

FDA received the submission on May 29, 2025 and issued its decision on Sep 16, 2025, 110 days later.

← All decisions in September 2025