510(k) Report

FDA applicant

Avotec, Inc.

Jensen Beach, FL1 decision1993–19930 recalls

FDA records 1 decision for Avotec, Inc. (Jensen Beach, FL) in 1993: 1 510(k) clearance. 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 Avotec, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Avotec, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Avotec, 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 Imaging1decision

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.

  • K921891Silent ScanAvotec, Inc. · 19932cite it

What has FDA decided for it lately?

  • K921891Silent ScanAvotec, Inc. · 1993

The one decision as Avotec, Inc. →