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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 / K261655

510(k) cleared

RT Elements (4.6)

Brainlab SE · Oct 5, 2026 · K261655

FDA cleared the RT Elements (4.6) from Brainlab SE on Oct 5, 2026 under K261655, a traditional 510(k). The device falls under product code MUJ, System, Planning, Radiation Therapy Treatment, regulated at 21 CFR 892.5050 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on May 19, 2026. The decision came 139 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Brainlab SE has 2 other decisions in the tracker over the last 12 months: K262257 (Spine Planning (3.0); Spine & Trauma Navigation; Alignment System Spine), K254010 (ExacTrac Dynamic (2.0.2); ExacTrac Dynamic Surface).

Questions & Answers

What did FDA clear under K261655?

K261655 is the FDA 510(k) for RT Elements (4.6), submitted by Brainlab SE. FDA's decision date was Oct 5, 2026, under product code MUJ (System, Planning, Radiation Therapy Treatment).

Who makes the RT Elements (4.6)?

Brainlab SE, based in Munich, is the applicant of record for K261655.

How long did the K261655 review take?

FDA received the submission on May 19, 2026 and issued its decision on Oct 5, 2026, 139 days later.

← All decisions in October 2026

Sources