510(k) Report

FDA applicant

Resonex, Inc.

Sunnyvale, CA21 decisions1988–19940 recalls

FDA records 21 decisions for Resonex, Inc. (Sunnyvale, CA) from 1988 to 1994: 21 510(k) clearances. All are in product code LNH (System, Nuclear Magnetic Resonance Imaging). 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 Resonex, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Resonex, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Resonex, 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 Imaging21decisions

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.

  • K924154Kinematic Mri MoviemakerResonex, Inc. · 19922cite it

What has FDA decided for it lately?

  • K935369Fast Spin Echo (Fse)Resonex, Inc. · 1994
  • K935570Noise Filter for Paradigm Magnetic Resonance Imaging SystemResonex, Inc. · 1994
  • K931392Ecg Gating UnitResonex, Inc. · 1993
  • K9238703DTOF MraResonex, Inc. · 1993
  • K924154Kinematic Mri MoviemakerResonex, Inc. · 1992
  • K9238233D ImagingResonex, Inc. · 1992
  • K922677Magnetization Transfer ContrastResonex, Inc. · 1992
  • K920254Coils for RX4000 & RX5000 Mri SystemsResonex, Inc. · 1992

All 21 as Resonex, Inc. →