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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 / March 2026 / K253574

510(k) cleared

SOMATOM X.cite; SOMATOM X.ceed

Siemens Medical Solutions USA, Inc. · Mar 20, 2026 · K253574

FDA cleared the SOMATOM X.cite; SOMATOM X.ceed from Siemens Medical Solutions USA, Inc. on Mar 20, 2026 under K253574, a traditional 510(k). The device falls under product code JAK, System, X-Ray, Tomography, Computed, regulated at 21 CFR 892.1750 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Nov 17, 2025. The decision came 123 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 K253574?

K253574 is the FDA 510(k) for SOMATOM X.cite; SOMATOM X.ceed, submitted by Siemens Medical Solutions USA, Inc.. FDA's decision date was Mar 20, 2026, under product code JAK (System, X-Ray, Tomography, Computed).

Who makes the SOMATOM X.cite; SOMATOM X.ceed?

Siemens Medical Solutions USA, Inc., based in Knoxville, TN, is the applicant of record for K253574.

How long did the K253574 review take?

FDA received the submission on Nov 17, 2025 and issued its decision on Mar 20, 2026, 123 days later.

← All decisions in March 2026