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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 / October 2026 / K262412

510(k) cleared

Coronis Fusion 4MP (MDCC-4630); Coronis Fusion 6MP (MDCC-6630)

Barco NV · Oct 2, 2026 · K262412

FDA cleared the Coronis Fusion 4MP (MDCC-4630); Coronis Fusion 6MP (MDCC-6630) from Barco NV on Oct 2, 2026 under K262412, a special 510(k). The device falls under product code PGY, Display, Diagnostic Radiology, regulated at 21 CFR 892.2050 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Jul 15, 2026. The decision came 79 days later, inside the 90 FDA-day goal for a 510(k).

Barco NV has one other decision in the tracker over the last 12 months: K261469 (Nexxis 2;Nexxis OR 2;NMS 2;MNA-240;MNA-4x0 (Where x may be any numeric character).).

Questions & Answers

What did FDA clear under K262412?

K262412 is the FDA 510(k) for Coronis Fusion 4MP (MDCC-4630); Coronis Fusion 6MP (MDCC-6630), submitted by Barco NV. FDA's decision date was Oct 2, 2026, under product code PGY (Display, Diagnostic Radiology).

Who makes the Coronis Fusion 4MP (MDCC-4630); Coronis Fusion 6MP (MDCC-6630)?

Barco NV, based in Kortrijk, is the applicant of record for K262412.

How long did the K262412 review take?

FDA received the submission on Jul 15, 2026 and issued its decision on Oct 2, 2026, 79 days later.

← All decisions in October 2026

Sources