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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 / November 2025 / K252570

510(k) cleared

EzSensor HD, EzSensor UHD

Qpix Solutions, Inc. · Nov 10, 2025 · K252570

FDA cleared the EzSensor HD, EzSensor UHD from Qpix Solutions, Inc. on Nov 10, 2025 under K252570, a special 510(k). The device falls under product code MUH, System, X-Ray, Extraoral Source, Digital, regulated at 21 CFR 872.1800 as a Class 2 device. The review panel was Dental.

FDA logged the submission as received on Aug 14, 2025. The decision came 88 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Qpix Solutions, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252570?

K252570 is the FDA 510(k) for EzSensor HD, EzSensor UHD, submitted by Qpix Solutions, Inc.. FDA's decision date was Nov 10, 2025, under product code MUH (System, X-Ray, Extraoral Source, Digital).

Who makes the EzSensor HD, EzSensor UHD?

Qpix Solutions, Inc., based in Morrisville, NC, is the applicant of record for K252570.

How long did the K252570 review take?

FDA received the submission on Aug 14, 2025 and issued its decision on Nov 10, 2025, 88 days later.

← All decisions in November 2025