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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 / K263033

510(k) cleared

Dental Computed Tomography X-ray System (Rubik XSmart, Rubik X1, Rubik X3) (Matrix 7000, Matrix 7800)

Fussen Technology Co., Ltd. · Sep 30, 2026 · K263033

FDA cleared the Dental Computed Tomography X-ray System (Rubik XSmart, Rubik X1, Rubik X3) (Matrix 7000, Matrix 7800) from Fussen Technology Co., Ltd. on Sep 30, 2026 under K263033, a special 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 Aug 31, 2026. The decision came 30 days later, inside the 90 FDA-day goal for a 510(k).

Fussen Technology Co., Ltd. has one other decision in the tracker over the last 12 months: K251842 (Dental Computed Tomography X-ray System).

Questions & Answers

What did FDA clear under K263033?

K263033 is the FDA 510(k) for Dental Computed Tomography X-ray System (Rubik XSmart, Rubik X1, Rubik X3) (Matrix 7000, Matrix 7800), submitted by Fussen Technology Co., Ltd.. FDA's decision date was Sep 30, 2026, under product code OAS (X-Ray, Tomography, Computed, Dental).

Who makes the Dental Computed Tomography X-ray System (Rubik XSmart, Rubik X1, Rubik X3) (Matrix 7000, Matrix 7800)?

Fussen Technology Co., Ltd., based in Shenzhen, is the applicant of record for K263033.

How long did the K263033 review take?

FDA received the submission on Aug 31, 2026 and issued its decision on Sep 30, 2026, 30 days later.

← All decisions in September 2026

Sources