510(k) Report

FDA applicant

Ge Medical Systems Israel, Ultrasound, Ltd.

Waukesha, WI3 decisions2008–20094 recalls

FDA records 3 decisions for Ge Medical Systems Israel, Ultrasound, Ltd. (Waukesha, WI) from 2008 to 2009: 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 3 predicates, 1 of them its own earlier devices. 4 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 Ge Medical Systems Israel, Ultrasound, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2009

2008: 12009: 2
2008high 2 (2009) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

4in 2022

2022: 4
2008high 4 (2022) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — Ge Medical Systems Israel, Ultrasound, Ltd. by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

See the 510(k) Report

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 3 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 6 times; 1 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.

  • K092079Modification to GE Vivid S5 and S6 Diagnostic UltrasoundGe Medical Systems Israel, Ultrasound, Ltd. · 20094cite it
  • K092140GE Vivid I Diagnostic Ultrasound, GE Vivid Q Diagnostic UltrasoundGe Medical Systems Israel, Ultrasound, Ltd. · 20091cites it
  • K082374Vivid I and Vivid QGe Medical Systems Israel, Ultrasound, Ltd. · 20081cites it

What has FDA decided for it lately?

  • K092140GE Vivid I Diagnostic Ultrasound, GE Vivid Q Diagnostic UltrasoundGe Medical Systems Israel, Ultrasound, Ltd. · 20092 recalls
  • K092079Modification to GE Vivid S5 and S6 Diagnostic UltrasoundGe Medical Systems Israel, Ultrasound, Ltd. · 20092 recalls
  • K082374Vivid I and Vivid QGe Medical Systems Israel, Ultrasound, Ltd. · 20082 recalls

All 3 as Ge Medical Systems Israel, Ultrasound, Ltd. →

What has been recalled?

4 recalls linked to its devices; the latest:

  • K071985Vivid S5 Ultrasound. Used in ultrasound imaging and analysis in Fetal/Obstetrics…Nov 10, 2022Class II
  • K071985Vivid S6 ultrasound. Used in ultrasound imaging and analysis in Fetal/Obstetrics…Nov 10, 2022Class II
  • K033139Vivid i ultrasound. Marketed under the following 510(k) numbers: K033139, K061525…Nov 10, 2022Class II
  • K082374Vivid q ultrasound. Used in ultrasound imaging and analysis in Fetal/Obstetrics…Nov 10, 2022Class II