510(k) Report

FDA applicant

Deerfield Imaging, Inc.

Chaska, MN2 decisions2021–20244 recalls

FDA records 2 decisions for Deerfield Imaging, Inc. (Chaska, MN) from 2021 to 2024: 2 510(k) clearances. All are in product code LNH (System, Nuclear Magnetic Resonance Imaging). Its devices cite 2 predicates, 1 of them its own earlier devices. 4 recalls are linked to its devices, 4 Class I.

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 Deerfield Imaging, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2021: 12024: 1
2021high 1 (2021) · low 0 (2022)2026

2026 so far, outlined.

Recalls per year

4in 2025

2025: 4, 4 Class I
2021high 4 (2025) · low 0 (2021)2026

Class I Class II/III not classified

FIG. 1 — Deerfield Imaging, Inc. by year, 2021–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Deerfield Imaging, Inc.’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?

  • LNHSystem, Nuclear Magnetic Resonance Imaging2decisions

Whose devices does it build on?

Its devices cite 2 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 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.

  • K212367IMRIS iMRI 3T VDeerfield Imaging, Inc. · 20212cite it

What has FDA decided for it lately?

  • K240157InVision™ 1.5 Surgical TheatreDeerfield Imaging, Inc. · 2024
  • K212367IMRIS iMRI 3T VDeerfield Imaging, Inc. · 20214 Class I recalls

All 2 as Deerfield Imaging, Inc. →

What has been recalled?

4 recalls linked to its devices; the latest:

  • K083137IMRIS Operating Suite, iMRI 3T S, containing Siemens 3 Tesla MRI Magnet, SkyraSep 30, 2025Class I
  • K083137IMRIS Operating Suite, Neuro III-SV iMRI System, iMRX System, containing Siemens 3 Tesla…Sep 30, 2025Class I
  • K083137IMRIS Operating Suite, IMRIS iMRI 3T V, containing Siemens 3 Tesla MRI Magnet, vIDASep 30, 2025Class I
  • K083137IMRIS Operating Suite, InVision 3T Operating Suite, containing Siemens 3 Tesla MRI…Sep 30, 2025Class I