510(k) Report

FDA applicant

Resonance Technology, Inc.

Northridge, CA1 decision2000–20002 recalls

FDA records 1 decision for Resonance Technology, Inc. (Northridge, CA) in 2000: 1 510(k) clearance. All are in product code LNH (System, Nuclear Magnetic Resonance Imaging). Its devices cite 1 predicate, 0 of them its own earlier devices. 2 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 Resonance Technology, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Resonance Technology, Inc. since 2007.

Recalls per year

2in 2007

2007: 2
2007high 2 (2007) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — Resonance Technology, 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

Whose devices does it build on?

Its devices cite 1 predicate; 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.

  • K994351M.R. Vision 2000 Ultra Audio Visual System / Commander X6 SystemResonance Technology, Inc. · 20001cites it

What has FDA decided for it lately?

  • K994351M.R. Vision 2000 Ultra Audio Visual System / Commander X6 SystemResonance Technology, Inc. · 20002 recalls

The one decision as Resonance Technology, Inc. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K994351Headset Model Number RTC-551-070 for use with the Serene Sound Digital MRI Compatible…May 14, 2007
  • K994351Headset Model Number RTC-2K for use with the Serene Sound Digital MRI Compatible High…May 14, 2007

Other applicant names beginning “Resonance”

FDA records each applicant name separately; these may or may not be the same firm.

Resonance Innovations, LLC 8Resonance Health Analysis Services Pty, Ltd. 7