510(k) Report

FDA applicant

Resoundant, Inc.

Rochester, MN2 decisions2019–20200 recalls

FDA records 2 decisions for Resoundant, Inc. (Rochester, MN) from 2019 to 2020: 2 510(k) clearances. Most are in product codes LLZ (System, Image Processing, Radiological) and LNH (System, Nuclear Magnetic Resonance Imaging). Its devices cite 2 predicates, 0 of them its own earlier devices. 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 Resoundant, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2019: 12020: 1
2019high 1 (2019) · low 0 (2021)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2019.

FIG. 1 — Resoundant, Inc. by year, 2019–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Resoundant, 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?

  • LLZSystem, Image Processing, Radiological1decision
  • LNHSystem, Nuclear Magnetic Resonance Imaging1decision

Whose devices does it build on?

Its devices cite 2 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.

  • K201389Resoundant Acoustic Driver SystemResoundant, Inc. · 20201cites it

What has FDA decided for it lately?

  • K201389Resoundant Acoustic Driver SystemResoundant, Inc. · 2020
  • K183193MREplus+ SoftwareResoundant, Inc. · 2019

All 2 as Resoundant, Inc. →