510(k) Report

FDA applicant

Advanced Imaging Research, Inc.

Cleveland, OH3 decisions2003–20090 recalls

FDA records 3 decisions for Advanced Imaging Research, Inc. (Cleveland, OH) from 2003 to 2009: 3 510(k) clearances. All are in product code MOS (Coil, Magnetic Resonance, Specialty). Its devices cite 3 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, radiology panel, where it files most

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

FDA decisions per year

2in 2009

2009: 2
2007high 2 (2009) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Advanced Imaging Research, Inc. 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?

  • MOSCoil, Magnetic Resonance, Specialty3decisions

Whose devices does it build on?

Its devices cite 3 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 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.

  • K023929Magnetic Resonance Diagnostic DeviceAdvanced Imaging Research, Inc. · 20033cite it

What has FDA decided for it lately?

  • K083539Infant Cardiac ArrayAdvanced Imaging Research, Inc. · 2009
  • K083541Neonate Head and Body CoilsAdvanced Imaging Research, Inc. · 2009
  • K023929Magnetic Resonance Diagnostic DeviceAdvanced Imaging Research, Inc. · 2003

All 3 as Advanced Imaging Research, Inc. →