510(k) Report

FDA applicant

Siemens Medical Solutions Inc. Ultrasound Group

Moutain View, CA1 decision2016–20161 recall

FDA records 1 decision for Siemens Medical Solutions Inc. Ultrasound Group (Moutain View, CA) in 2016: 1 510(k) clearance. All are in product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic). Its devices cite 1 predicate, 0 of them its own earlier devices. 1 recall is 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 Group’s devices, and how often a recall has named them.

FDA decisions per year

1in 2016

2016: 1
2016high 1 (2016) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

1in 2018

2018: 1
2016high 1 (2018) · low 0 (2016)2026

Class I Class II/III not classified

FIG. 1 — Siemens Medical Solutions Inc. Ultrasound Group by year, 2016–2026Sources: 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 1 predicate; 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.

  • K162221ACUSON SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions Inc. Ultrasound Group · 20162cite it

What has FDA decided for it lately?

  • K162221ACUSON SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions Inc. Ultrasound Group · 20161 recall

The one decision as Siemens Medical Solutions Inc. Ultrasound Group →

What has been recalled?

1 recall linked to its devices; the latest:

  • K162221ACUSON SC2000 Ultrasound System Product Usage: The SC2000 ultrasound imaging system is…Jan 26, 2018Class II