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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 / K251842

510(k) cleared

Dental Computed Tomography X-ray System

Fussen Technology Co., Ltd. · Nov 13, 2025 · K251842

FDA cleared the Dental Computed Tomography X-ray System from Fussen Technology Co., Ltd. on Nov 13, 2025 under K251842, a traditional 510(k). The device falls under product code OAS, X-Ray, Tomography, Computed, Dental, regulated at 21 CFR 892.1750 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Jun 16, 2025. The decision came 150 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Fussen Technology Co., Ltd. has one other decision in the tracker over the last 12 months: K263033 (Dental Computed Tomography X-ray System (Rubik XSmart, Rubik X1, Rubik X3) (Matrix 7000, Matrix 7800)).

Questions & Answers

What did FDA clear under K251842?

K251842 is the FDA 510(k) for Dental Computed Tomography X-ray System, submitted by Fussen Technology Co., Ltd.. FDA's decision date was Nov 13, 2025, under product code OAS (X-Ray, Tomography, Computed, Dental).

Who makes the Dental Computed Tomography X-ray System?

Fussen Technology Co., Ltd., based in Shenzhen, is the applicant of record for K251842.

How long did the K251842 review take?

FDA received the submission on Jun 16, 2025 and issued its decision on Nov 13, 2025, 150 days later.

← All decisions in November 2025

Sources