510(k) Report

FDA applicant

Neovision Corp.

Seattle, WA2 decisions1996–19980 recalls

FDA records 2 decisions for Neovision Corp. (Seattle, WA) from 1996 to 1998: 2 510(k) clearances. All are in product code IYO (System, Imaging, Pulsed Echo, Ultrasonic). 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 Neovision Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Neovision Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Neovision Corp.’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?

  • IYOSystem, Imaging, Pulsed Echo, Ultrasonic2decisions

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K980423Sonopsy LA SystemNeovision Corp. · 19981cites it

What has FDA decided for it lately?

  • K980423Sonopsy LA SystemNeovision Corp. · 1998
  • K951999Holopsy SystemNeovision Corp. · 1996

All 2 as Neovision Corp. →