510(k) Report

FDA applicant

Siemens Medical Solutions USA, Inc., Ultrasound DI

Mountainview, CA11 decisions2007–201720 recalls

FDA records 11 decisions for Siemens Medical Solutions USA, Inc., Ultrasound DI (Mountainview, CA) from 2007 to 2017: 11 510(k) clearances. Most are in product codes IYN (System, Imaging, Pulsed Doppler, Ultrasonic) and IYO (System, Imaging, Pulsed Echo, Ultrasonic). Its devices cite 25 predicates, 5 of them its own earlier devices. 20 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 DI’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2007: 42008: 42011: 22017: 1
2007high 4 (2007) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

1in 2015

2007: 22008: 22009: 72010: 52011: 22013: 12015: 1
2007high 7 (2009) · low 0 (2012)2026

Class I Class II/III not classified

FIG. 1 — Siemens Medical Solutions USA, Inc., Ultrasound DI by year, 2007–2026Sources: 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, Ultrasonic8decisions
  • IYOSystem, Imaging, Pulsed Echo, Ultrasonic2decisions
  • JAKSystem, X-Ray, Tomography, Computed1decision

Whose devices does it build on?

Its devices cite 25 predicates; 5 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 40 times; 5 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.

  • K112596Acuson S2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 20116cite it
  • K071036Modification to Acuson X300 Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 20076cite it
  • K081148Siemens Acuson 2000 Ultrasound System with Abvs TransducerSiemens Medical Solutions USA, Inc., Ultrasound DI · 20086cite it
  • K072365Sequoia Plus Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 20076cite it
  • K072090Siemens Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc., Ultrasound DI · 20075cite it
  • K113179Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 20114cite it

What has FDA decided for it lately?

  • K163289syngo. CT Single Source Dual Energy (twin beam)Siemens Medical Solutions USA, Inc., Ultrasound DI · 2017
  • K113179Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2011
  • K112596Acuson S2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2011
  • K081148Siemens Acuson 2000 Ultrasound System with Abvs TransducerSiemens Medical Solutions USA, Inc., Ultrasound DI · 20083 recalls
  • K082142Acuson S2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 20088 recalls
  • K081121Modification to Acuson X150 Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2008
  • K080760Acuson X300 Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2008
  • K072365Sequoia Plus Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 20073 recalls

All 11 as Siemens Medical Solutions USA, Inc., Ultrasound DI →

What has been recalled?

20 recalls linked to its devices; the latest:

  • K081148ACUSON S2000 Automated Breast Volume Scanner (ABVS), model number 10434730. The affected…Jan 12, 2015Class II
  • K081148ACUSON S2000 Automated Breast Volume Scanner (ABVS); Model number 10042541 Distributed…Jan 18, 2013Class II
  • K081148Siemens brand ACUSON S2000, Model 10434730, ABVS ultrasound systems; Affected…Mar 28, 2011
  • K082142ACUSON S2000 ultrasound system Manufactured by Siemens Medical Solutions USA, Inc.…Mar 15, 2011
  • K0723654Z1c matrix array transducer which is used with ACUSON SC2000 ultrasound system. Siemens…Sep 29, 2010
  • K072365ACUSON SC 2000 ultrasound system. Siemens Medical Solutions USA, Inc. Business Unit…Sep 29, 2010