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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 / K263048

510(k) cleared

Syngo Carbon Space (VA4)

Siemens Healthineers AG · Sep 29, 2026 · K263048

FDA cleared the Syngo Carbon Space (VA4) from Siemens Healthineers AG on Sep 29, 2026 under K263048, a traditional 510(k) reviewed through the Third Party Review Program. The device falls under product code LLZ, System, Image Processing, Radiological, regulated at 21 CFR 892.2050 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Aug 31, 2026. The decision came 29 days later, inside the 90 FDA-day goal for a 510(k).

Siemens Healthineers AG has 5 other decisions in the tracker over the last 12 months: K260852 (MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.Pure), K253690 (LungMaps), K253023 (BIOGRAPH One), K253495 (syngo.MR Applications (VB80)).

Questions & Answers

What did FDA clear under K263048?

K263048 is the FDA 510(k) for Syngo Carbon Space (VA4), submitted by Siemens Healthineers AG. FDA's decision date was Sep 29, 2026, under product code LLZ (System, Image Processing, Radiological).

Who makes the Syngo Carbon Space (VA4)?

Siemens Healthineers AG, based in Forchheim, is the applicant of record for K263048.

How long did the K263048 review take?

FDA received the submission on Aug 31, 2026 and issued its decision on Sep 29, 2026, 29 days later.

← All decisions in September 2026

Sources