510(k) Report

FDA applicant

Oni, Inc.

North Andover, MA1 decision2000–20001 recall

FDA records 1 decision for Oni, Inc. (North Andover, MA) in 2000: 1 510(k) clearance. All are in product code LNH (System, Nuclear Magnetic Resonance Imaging). 1 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 Oni, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Oni, Inc. since 2007.

Recalls per year

1in 2021

2021: 1
2007high 1 (2021) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Oni, Inc. 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?

  • LNHSystem, Nuclear Magnetic Resonance Imaging1decision

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.

  • K001773OrthoneOni, Inc. · 20002cite it

What has FDA decided for it lately?

  • K001773OrthoneOni, Inc. · 20001 recall

The one decision as Oni, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K001773GE Healthcare MR superconducting magnets, a component of GE Healthcare Orthone (1.0T MSK…Dec 23, 2021Class II