510(k) Report

FDA applicant

Acuson Corp.

Mountain View, CA37 decisions1988–200211 recalls

FDA records 37 decisions for Acuson Corp. (Mountain View, CA) from 1988 to 2002: 37 510(k) clearances. Most are in product codes ITX (Transducer, Ultrasonic, Diagnostic) and IYO (System, Imaging, Pulsed Echo, Ultrasonic). Its devices cite 20 predicates, 11 of them its own earlier devices. 11 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 Acuson Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Acuson Corp. since 2007.

Recalls per year

3in 2016

2007: 12009: 12014: 22016: 3
2007high 3 (2016) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — Acuson Corp. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • ITXTransducer, Ultrasonic, Diagnostic11decisions
  • IYOSystem, Imaging, Pulsed Echo, Ultrasonic10decisions
  • IYNSystem, Imaging, Pulsed Doppler, Ultrasonic7decisions
  • MAAMonitor, Fetal Doppler Ultrasound3decisions
  • LLZSystem, Image Processing, Radiological2decisions
  • DQCPhonocardiograph1decision

Also: FCG (1), JTX (1), DQO (1).

Whose devices does it build on?

Its devices cite 20 predicates; 11 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 57 times; 11 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.

  • K022567Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 200210cite it
  • K992631Acunav Diagnostic Ultrasound CatheterAcuson Corp. · 19999cite it
  • K973767Harmonic Imaging with ContrastAcuson Corp. · 19978cite it
  • K991805Aspen Ultrasound with Freestyle Imaging OptionAcuson Corp. · 19996cite it
  • K021497Cypress Ultrasound SystemAcuson Corp. · 20025cite it
  • K010950Cypress SystemAcuson Corp. · 20014cite it

What has FDA decided for it lately?

  • K023772Kinetdx Picture Archiving and Communications SystemAcuson Corp. · 20025 recalls
  • K022896CSV12 Software ViewerAcuson Corp. · 2002
  • K022567Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
  • K021497Cypress Ultrasound SystemAcuson Corp. · 20022 recalls
  • K010950Cypress SystemAcuson Corp. · 2001
  • K0028073D Organ Assessment W/ Magnetic Position SensingAcuson Corp. · 2000
  • K992631Acunav Diagnostic Ultrasound CatheterAcuson Corp. · 19991 recall
  • K992580Fetal Assessment CapAcuson Corp. · 1999

All 37 as Acuson Corp. →

What has been recalled?

11 recalls linked to its devices; the latest:

  • K023772Syngo Dynamics; Kinetdx Picture Archiving and Communications SystemApr 14, 2016Class II
  • K023772software for Syngo Dynamics a Picture Archiving and Communication System (PACS) intended…Jan 29, 2016Class II
  • K023772Siemens Syngo Dynamics-a Picture Archiving and Communication System (PACS) Model…Jan 25, 2016Class II
  • K023772Syngo Dynamics v9.5 system. A Picture Archiving and Communication System (PACS) intended…Apr 3, 2014Class II
  • K023772syngo Dynamics Picture Archiving and Communication System (PACS). Model numbers…Jan 27, 2014Class II
  • K033650Siemens Medical Solutions USA, Inc., ACUSON AcuNav ultrasound catheters when using…Mar 20, 2009

Other applicant names beginning “Acuson”

FDA records each applicant name separately; these may or may not be the same firm.

Acuson Computed Sonography 24