510(k) Report

FDA applicant

Siemens Medical Solutions USA, Inc. Ultrasound Gro

Moutain View, CA3 decisions2012–20133 recalls

FDA records 3 decisions for Siemens Medical Solutions USA, Inc. Ultrasound Gro (Moutain View, CA) from 2012 to 2013: 3 510(k) clearances. Most are in product codes IYN (System, Imaging, Pulsed Doppler, Ultrasonic) and IYO (System, Imaging, Pulsed Echo, Ultrasonic). Its devices cite 19 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 Gro’s devices, and how often a recall has named them.

FDA decisions per year

2in 2013

2012: 12013: 2
2012high 2 (2013) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

2in 2015

2014: 12015: 2
2012high 2 (2015) · low 0 (2012)2026

Class I Class II/III not classified

FIG. 1 — Siemens Medical Solutions USA, Inc. Ultrasound Gro by year, 2012–2026Sources: 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, Ultrasonic2decisions
  • IYOSystem, Imaging, Pulsed Echo, Ultrasonic1decision

Whose devices does it build on?

Its devices cite 19 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.

  • K132654Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. Ultrasound Gro · 20133cite it
  • K132804Acuson S1000 / S2000 / S3000Siemens Medical Solutions USA, Inc. Ultrasound Gro · 20132cite it

What has FDA decided for it lately?

  • K132804Acuson S1000 / S2000 / S3000Siemens Medical Solutions USA, Inc. Ultrasound Gro · 20133 recalls
  • K132654Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. Ultrasound Gro · 2013
  • K121646Acuson X150 Diagnostic Ultrasound System Sonovista X150 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. Ultrasound Gro · 2012

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

What has been recalled?

3 recalls linked to its devices; the latest:

  • K132804ACUSON S2000 and ACUSON S3000 ultrasound systems with the Virtual Touch IQ option; Model…Jun 25, 2015Class II
  • K132804ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version…Jun 25, 2015Class II
  • K132804ACUSON S Family Ultrasound Systems at software versions VC25D, VC30A and VC30B; (S2000…Jun 3, 2014Class II