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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 / June 2026 / K253678

510(k) cleared

MAMMOMAT B.brilliant (11372950)

Siemens Medical Solutions USA, Inc. · Jun 18, 2026 · K253678

FDA cleared the MAMMOMAT B.brilliant (11372950) from Siemens Medical Solutions USA, Inc. on Jun 18, 2026 under K253678, a traditional 510(k). The device falls under product code MUE, Full Field Digital, System, X-Ray, Mammographic, regulated at 21 CFR 892.1715 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Nov 21, 2025. The decision came 209 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 K253678?

K253678 is the FDA 510(k) for MAMMOMAT B.brilliant (11372950), submitted by Siemens Medical Solutions USA, Inc.. FDA's decision date was Jun 18, 2026, under product code MUE (Full Field Digital, System, X-Ray, Mammographic).

Who makes the MAMMOMAT B.brilliant (11372950)?

Siemens Medical Solutions USA, Inc., based in Malvern, PA, is the applicant of record for K253678.

How long did the K253678 review take?

FDA received the submission on Nov 21, 2025 and issued its decision on Jun 18, 2026, 209 days later.

← All decisions in June 2026