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Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets

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).

Qpix Solutions, Inc. has one other decision in the tracker over the last 12 months: K261663 (EzSensor HD).

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

Sources