510(k) Report

FDA applicant

Siemens Medical Solutions USA, Inc. Ultrasound Group

Moutain View, CA3 decisions2015–20183 recalls

FDA records 3 decisions for Siemens Medical Solutions USA, Inc. Ultrasound Group (Moutain View, CA) from 2015 to 2018: 3 510(k) clearances. All are in product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic). Its devices cite 3 predicates, 0 of them its own earlier devices. 3 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 USA, Inc. Ultrasound Group’s devices, and how often a recall has named them.

FDA decisions per year

1in 2018

2015: 12017: 12018: 1
2015high 1 (2015) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

2in 2019

2017: 12019: 2
2015high 2 (2019) · low 0 (2015)2026

Class I Class II/III not classified

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

Planning a device like Siemens Medical Solutions USA, Inc.…’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • IYNSystem, Imaging, Pulsed Doppler, Ultrasonic3decisions

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 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.

  • K163635ACUSON S1000/S2000/S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc. Ultrasound Group · 20173cite it
  • K152369ACUSON S1000, S2000, S3000 Diagnostic Ultrasuond SystemSiemens Medical Solutions USA, Inc. Ultrasound Group · 20152cite it

What has FDA decided for it lately?

  • K173981ACUSON NX2 Diagnostic Ultrasound System, ACUSON NX2 Elite Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. Ultrasound Group · 20182 recalls
  • K163635ACUSON S1000/S2000/S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc. Ultrasound Group · 20171 recall
  • K152369ACUSON S1000, S2000, S3000 Diagnostic Ultrasuond SystemSiemens Medical Solutions USA, Inc. Ultrasound Group · 2015

All 3 as Siemens Medical Solutions USA, Inc. Ultrasound Group →

What has been recalled?

3 recalls linked to its devices; the latest:

  • K161787ACUSON NX2 Diagnostic Ultrasound System, Model # 11284381, RX Only, Siemens Medical…Jan 28, 2019Class II
  • K173981ACUSON NX2 Elite Diagnostic Ultrasound System, Model # 11284500, RX Only, Siemens…Jan 28, 2019Class II
  • K16363518L6 HD transducer on the ACUSON S Family ultrasound systems with software versions…Mar 30, 2017Class II