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: K253786 (syngo.CT Coronary Cockpit), K260844 (ACUSON Sequoia Diagnostic Ultrasound System;ACUSON Sequoia Select Diagnostic Ultrasound System;ACUSON Origin Diagnostic Ultrasound System;ACUSON Origin ICE Diagnostic Ultrasound System), K261315 (Symbia Pro.specta Q3 (11364751);Symbia Pro.specta X3 (11364752);Symbia Pro.specta X7 (11364753);Symbia Pro.specta VA40 Family), K254184 (syngo Application Software).