510(k) Report

FDA applicant

Siemens Medical Solutions, Inc., Ultrasound Division

Moutain View, CA1 decision2015–20152 recalls

FDA records 1 decision for Siemens Medical Solutions, Inc., Ultrasound Division (Moutain View, CA) in 2015: 1 510(k) clearance. All are in product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic). Its devices cite 2 predicates, 0 of them its own earlier devices. 2 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, radiology panel, where it files most

How often FDA has decided Siemens Medical Solutions, Inc., Ultrasound Division’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2015: 1
2015high 1 (2015) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

2in 2019

2019: 2
2015high 2 (2019) · low 0 (2015)2026

Class I Class II/III not classified

FIG. 1 — Siemens Medical Solutions, Inc., Ultrasound Division by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • IYNSystem, Imaging, Pulsed Doppler, Ultrasonic1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K152469ACUSON NX3 Elite / NX3 Diagnostic Ultrasound SystemSiemens Medical Solutions, Inc., Ultrasound Division · 20152cite it

What has FDA decided for it lately?

  • K152469ACUSON NX3 Elite / NX3 Diagnostic Ultrasound SystemSiemens Medical Solutions, Inc., Ultrasound Division · 20152 recalls

The one decision as Siemens Medical Solutions, Inc., Ultrasound Division →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K152469ACUSON NX3 Elite Diagnostic Ultrasound System, Model # 11235411, RX Only, Siemens…Jan 28, 2019Class II
  • K152469ACUSON NX3 Diagnostic Ultrasound System, Model # 11235612, RX Only, Siemens Medical…Jan 28, 2019Class II