510(k) Report

FDA applicant

Modulated Imaging, Inc.

Irvine, CA2 decisions2016–20180 recalls

FDA records 2 decisions for Modulated Imaging, Inc. (Irvine, CA) from 2016 to 2018: 2 510(k) clearances. All are in product code MUD (Oximeter, Tissue Saturation). Its devices cite 2 predicates, 1 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, cardiovascular panel, where it files most

How often FDA has decided Modulated Imaging, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2018

2016: 12018: 1
2016high 1 (2016) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2016.

FIG. 1 — Modulated Imaging, Inc. by year, 2016–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Modulated Imaging, 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?

  • MUDOximeter, Tissue Saturation2decisions

Whose devices does it build on?

Its devices cite 2 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 1 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.

  • K153426Ox-Imager CSModulated Imaging, Inc. · 20161cites it
  • K181623Clarifi Imaging SystemModulated Imaging, Inc. · 20181cites it

What has FDA decided for it lately?

  • K181623Clarifi Imaging SystemModulated Imaging, Inc. · 2018
  • K153426Ox-Imager CSModulated Imaging, Inc. · 2016

All 2 as Modulated Imaging, Inc. →