510(k) Report

FDA applicant

Ge Healthcare Coils (Usa Instruments, Inc.)

Aurora, OH12 decisions2009–20261 recall

FDA records 12 decisions for Ge Healthcare Coils (Usa Instruments, Inc.) (Aurora, OH) from 2009 to 2026: 12 510(k) clearances. Most are in product codes MOS (Coil, Magnetic Resonance, Specialty) and KXH (Cradle, Patient, Radiologic). Since 2016 its 510(k)s took a median of 58 days from receipt to decision, against 52 for FDA’s reviews in the same codes and years. Its devices cite 13 predicates, 4 of them its own earlier devices. 1 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 Ge Healthcare Coils (Usa Instruments, Inc.)’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2009: 12010: 12011: 12012: 12013: 12015: 12017: 22018: 22023: 12026 (partial year): 1
2009high 2 (2017) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

1in 2019

2019: 1
2009high 1 (2019) · low 0 (2009)2026

Class I Class II/III not classified

FIG. 1 — Ge Healthcare Coils (Usa Instruments, Inc.) by year, 2009–2026Sources: 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, Specialty11decisions
  • KXHCradle, Patient, Radiologic1decision

How long do its 510(k) reviews take?

Since 2016, its 6 510(k)s took a median of 58 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 52 days; 3 of its 6 were faster than that.

Whose devices does it build on?

Its devices cite 13 predicates; 4 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 8 times; 4 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.

  • K172695AIR Anterior Array, AIR Posterior ArrayGe Healthcare Coils (Usa Instruments, Inc.) · 20172cite it
  • K16320548CH Head CoilGe Healthcare Coils (Usa Instruments, Inc.) · 20172cite it
  • K18066648CH Head CoilGe Healthcare Coils (Usa Instruments, Inc.) · 20181cites it
  • K0933483.0T 16 Channel Head Neck Spine CoilGe Healthcare Coils (Usa Instruments, Inc.) · 20091cites it
  • K1233271.5T Gem RT Open ArrayGe Healthcare Coils (Usa Instruments, Inc.) · 20131cites it
  • K1433893.0T GEM RT Open ArrayGe Healthcare Coils (Usa Instruments, Inc.) · 20151cites it

What has FDA decided for it lately?

  • K2537383.0T Air 32CH HnaGe Healthcare Coils (Usa Instruments, Inc.) · 2026
  • K2233783.0T 16ch AIR AAGe Healthcare Coils (Usa Instruments, Inc.) · 2023
  • K1825043.0T Air MP M, 3.0T Air MP LGe Healthcare Coils (Usa Instruments, Inc.) · 2018
  • K18066648CH Head CoilGe Healthcare Coils (Usa Instruments, Inc.) · 2018
  • K172695AIR Anterior Array, AIR Posterior ArrayGe Healthcare Coils (Usa Instruments, Inc.) · 20171 recall
  • K16320548CH Head CoilGe Healthcare Coils (Usa Instruments, Inc.) · 2017
  • K1433893.0T GEM RT Open ArrayGe Healthcare Coils (Usa Instruments, Inc.) · 2015
  • K1233271.5T Gem RT Open ArrayGe Healthcare Coils (Usa Instruments, Inc.) · 2013

All 12 as Ge Healthcare Coils (Usa Instruments, Inc.) →

What has been recalled?

1 recall linked to its devices; the latest:

  • K172695AIR Technology Anterior Array, Catalogue Numbers: (a) 5746694, (b) 5746695, (c) 5746696…Mar 19, 2019Class II