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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 / April 2026 / K254173

510(k) cleared

ARTIS icono floor; ARTIS icono biplane; ARTIS icono ceiling; ARTIS pheno

Siemens Medical Solutions USA, Inc. · Apr 24, 2026 · K254173

FDA cleared the ARTIS icono floor; ARTIS icono biplane; ARTIS icono ceiling; ARTIS pheno from Siemens Medical Solutions USA, Inc. on Apr 24, 2026 under K254173, a traditional 510(k). The device falls under product code OWB, Interventional Fluoroscopic X-Ray System, regulated at 21 CFR 892.1650 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Dec 23, 2025. The decision came 122 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Siemens Medical Solutions USA, Inc. has 8 other decisions in the tracker over the last 12 months: K260055 (syngo.CT Brain Quantification), K261696 (ACUNAV Luxera 4D ICE Catheter), K260488 (MULTIX Impact; MULTIX Impact C), K253786 (syngo.CT Coronary Cockpit).

Questions & Answers

What did FDA clear under K254173?

K254173 is the FDA 510(k) for ARTIS icono floor; ARTIS icono biplane; ARTIS icono ceiling; ARTIS pheno, submitted by Siemens Medical Solutions USA, Inc.. FDA's decision date was Apr 24, 2026, under product code OWB (Interventional Fluoroscopic X-Ray System).

Who makes the ARTIS icono floor; ARTIS icono biplane; ARTIS icono ceiling; ARTIS pheno?

Siemens Medical Solutions USA, Inc., based in Malvern, PA, is the applicant of record for K254173.

How long did the K254173 review take?

FDA received the submission on Dec 23, 2025 and issued its decision on Apr 24, 2026, 122 days later.

← All decisions in April 2026