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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 / September 2026 / K261663

510(k) cleared

EzSensor HD

Qpix Solutions, Inc. · Sep 30, 2026 · K261663

FDA cleared the EzSensor HD from Qpix Solutions, Inc. on Sep 30, 2026 under K261663, a traditional 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 May 20, 2026. The decision came 133 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Qpix Solutions, Inc. has one other decision in the tracker over the last 12 months: K252570 (EzSensor HD, EzSensor UHD).

Questions & Answers

What did FDA clear under K261663?

K261663 is the FDA 510(k) for EzSensor HD, submitted by Qpix Solutions, Inc.. FDA's decision date was Sep 30, 2026, under product code MUH (System, X-Ray, Extraoral Source, Digital).

Who makes the EzSensor HD?

Qpix Solutions, Inc., based in Morrisville, NC, is the applicant of record for K261663.

How long did the K261663 review take?

FDA received the submission on May 20, 2026 and issued its decision on Sep 30, 2026, 133 days later.

← All decisions in September 2026

Sources