510(k) Report

FDA applicant

Oni Medical Systems, Inc.

Wilmington, MA1 decision2008–20083 recalls

FDA records 1 decision for Oni Medical Systems, Inc. (Wilmington, MA) in 2008: 1 510(k) clearance. All are in product code LNH (System, Nuclear Magnetic Resonance Imaging). Its devices cite 3 predicates, 0 of them its own earlier devices. 3 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 Oni Medical Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2008

2008: 1
2008high 1 (2008) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

1in 2016

2011: 12013: 12016: 1
2008high 1 (2011) · low 0 (2008)2026

Class I Class II/III not classified

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

Planning a device like Oni Medical Systems, Inc.’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?

  • LNHSystem, Nuclear Magnetic Resonance Imaging1decision

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

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.

  • K080048MSK Extreme MR Scanner, Model AA5000Oni Medical Systems, Inc. · 20081cites it

What has FDA decided for it lately?

  • K080048MSK Extreme MR Scanner, Model AA5000Oni Medical Systems, Inc. · 20083 recalls

The one decision as Oni Medical Systems, Inc. →

What has been recalled?

3 recalls linked to its devices; the latest:

  • K080048MSK 1.5T Extreme MR Scanner, a diagnostic imaging deviceMay 9, 2016Class II
  • K080048MSK EXTREME MR SCANNER, MODEL AA5000 The intended for use as a diagnostic imaging device…Mar 28, 2013Class II
  • K080048GE HEALTHCARE, MSK 1.5T EXTREME MR SCANNER, MODEL AA5000. The MSK Extreme TM MR Scanner…Aug 29, 2011