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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 / K253864

510(k) cleared

NOMAD Pro 3

Dental Imaging Technologies Corporation · Mar 20, 2026 · K253864

FDA cleared the NOMAD Pro 3 from Dental Imaging Technologies Corporation on Mar 20, 2026 under K253864, a traditional 510(k). The device falls under product code EHD, Unit, X-Ray, Extraoral With Timer, regulated at 21 CFR 872.1800 as a Class 2 device. The review panel was Dental.

FDA logged the submission as received on Dec 3, 2025. The decision came 107 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 Dental Imaging Technologies Corporation in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253864?

K253864 is the FDA 510(k) for NOMAD Pro 3, submitted by Dental Imaging Technologies Corporation. FDA's decision date was Mar 20, 2026, under product code EHD (Unit, X-Ray, Extraoral With Timer).

Who makes the NOMAD Pro 3?

Dental Imaging Technologies Corporation, based in Quakertown, PA, is the applicant of record for K253864.

How long did the K253864 review take?

FDA received the submission on Dec 3, 2025 and issued its decision on Mar 20, 2026, 107 days later.

← All decisions in March 2026