510(k) Report

FDA applicant

Mirada Solutions, Ltd.

Knoxville, TN2 decisions2002–20040 recalls

FDA records 2 decisions for Mirada Solutions, Ltd. (Knoxville, TN) from 2002 to 2004: 2 510(k) clearances. All are in product code LLZ (System, Image Processing, Radiological). Its devices cite 8 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 Mirada Solutions, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Mirada Solutions, Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Mirada Solutions, Ltd. 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?

  • LLZSystem, Image Processing, Radiological2decisions

Whose devices does it build on?

Its devices cite 8 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 13 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.

  • K020546Fusion 7DMirada Solutions, Ltd. · 20029cite it
  • K033955RTISTMirada Solutions, Ltd. · 20044cite it

What has FDA decided for it lately?

  • K033955RTISTMirada Solutions, Ltd. · 2004
  • K020546Fusion 7DMirada Solutions, Ltd. · 2002

All 2 as Mirada Solutions, Ltd. →

Other applicant names beginning “Mirada”

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

Mirada Medical, Ltd. 8