510(k) Report

FDA applicant

Optoacoustics, Ltd.

Bonita Springs, FL1 decision2012–20120 recalls

FDA records 1 decision for Optoacoustics, Ltd. (Bonita Springs, FL) in 2012: 1 510(k) clearance. All are in product code 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 Optoacoustics, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2012

2012: 1
2012high 1 (2012) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2012.

FIG. 1 — Optoacoustics, Ltd. by year, 2012–2026Sources: 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 2 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K121239Mri Multi-Channel Optical Communication (Moc) System Imroc/Imroc IR Wirless OptoactiveOptoacoustics, Ltd. · 2012

The one decision as Optoacoustics, Ltd. →