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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 / K253752

510(k) cleared

ARTIS genio floor; ARTIS icono.explore floor

Siemens Medical Solutions USA, Inc. · Apr 23, 2026 · K253752

FDA cleared the ARTIS genio floor; ARTIS icono.explore floor from Siemens Medical Solutions USA, Inc. on Apr 23, 2026 under K253752, 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 Nov 25, 2025. The decision came 149 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 K253752?

K253752 is the FDA 510(k) for ARTIS genio floor; ARTIS icono.explore floor, submitted by Siemens Medical Solutions USA, Inc.. FDA's decision date was Apr 23, 2026, under product code OWB (Interventional Fluoroscopic X-Ray System).

Who makes the ARTIS genio floor; ARTIS icono.explore floor?

Siemens Medical Solutions USA, Inc., based in Malvern, PA, is the applicant of record for K253752.

How long did the K253752 review take?

FDA received the submission on Nov 25, 2025 and issued its decision on Apr 23, 2026, 149 days later.

← All decisions in April 2026