ACUSON Maple Diagnostic Ultrasound System; ACUSON Maple Select Diagnostic Ultrasound System

FDA cleared the ACUSON Maple Diagnostic Ultrasound System; ACUSON Maple Select Diagnostic Ultrasound System from Siemens Medical Solutions USA, Inc. on Nov 17, 2025 under K253487, a traditional 510(k) reviewed through the Third Party Review Program. The device falls under product code IYN, System, Imaging, Pulsed Doppler, Ultrasonic, regulated at 21 CFR 892.1550 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Oct 21, 2025. The decision came 27 days later, inside the 90 FDA-day goal for a 510(k).

Siemens Medical Solutions USA, Inc. has 8 other decisions in the tracker over the last 12 months: K253786 (syngo.CT Coronary Cockpit), K253678 (MAMMOMAT B.brilliant (11372950)), 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).