510(k) Report

FDA applicant

Diasonics Ultrasound

Santa Clara, CA2 decisions1996–19970 recalls

FDA records 2 decisions for Diasonics Ultrasound (Santa Clara, CA) from 1996 to 1997: 2 510(k) clearances. Most are in product codes IYN (System, Imaging, Pulsed Doppler, Ultrasonic) and ITX (Transducer, Ultrasonic, Diagnostic). No recall is 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 Diasonics Ultrasound’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Diasonics Ultrasound since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Diasonics Ultrasound 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?

  • IYNSystem, Imaging, Pulsed Doppler, Ultrasonic1decision
  • ITXTransducer, Ultrasonic, Diagnostic1decision

Who builds on its devices?

Later devices cite its devices 2 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.

  • K951998Diasonics Masters Series 5000 Ultrasound ScannerDiasonics Ultrasound · 19961cites it
  • K961002Diasonics Itnraoperative ProbesDiasonics Ultrasound · 19971cites it

What has FDA decided for it lately?

  • K961002Diasonics Itnraoperative ProbesDiasonics Ultrasound · 1997
  • K951998Diasonics Masters Series 5000 Ultrasound ScannerDiasonics Ultrasound · 1996

All 2 as Diasonics Ultrasound →

Other applicant names beginning “Diasonics”

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

Diasonics, Inc. 42