510(k) Report

FDA applicant

Us Asia Instruments, Inc.

Highland Heights, OH4 decisions1995–19970 recalls

FDA records 4 decisions for Us Asia Instruments, Inc. (Highland Heights, OH) from 1995 to 1997: 4 510(k) clearances. Most are in product codes LNH (System, Nuclear Magnetic Resonance Imaging) and MOS (Coil, Magnetic Resonance, Specialty). Its devices cite 6 predicates, 2 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 Us Asia Instruments, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Us Asia Instruments, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Us Asia Instruments, 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 Imaging3decisions
  • MOSCoil, Magnetic Resonance, Specialty1decision

Whose devices does it build on?

Its devices cite 6 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 9 times; 2 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.

  • K964531Profile 70000 Quadrature Volume Neck CoilUs Asia Instruments, Inc. · 19975cite it
  • K943440Profile 7000 C-Spine CoilUs Asia Instruments, Inc. · 19953cite it
  • K964753Matrix 3000 Flexible Spine CoilUs Asia Instruments, Inc. · 19971cites it

What has FDA decided for it lately?

  • K964820Maxim 7000 Quadrature Extremity Coil Model Number Qec-Gem-15AUs Asia Instruments, Inc. · 1997
  • K964753Matrix 3000 Flexible Spine CoilUs Asia Instruments, Inc. · 1997
  • K964531Profile 70000 Quadrature Volume Neck CoilUs Asia Instruments, Inc. · 1997
  • K943440Profile 7000 C-Spine CoilUs Asia Instruments, Inc. · 1995

All 4 as Us Asia Instruments, Inc. →