510(k) Report

FDA applicant

Ge Healthcare Japan Corporation

Hino, JP10 decisions2011–202615 recalls

FDA records 10 decisions for Ge Healthcare Japan Corporation (Hino, JP) from 2011 to 2026: 10 510(k) clearances. Most are in product codes JAK (System, X-Ray, Tomography, Computed) and LNH (System, Nuclear Magnetic Resonance Imaging). Since 2016 its 510(k)s took a median of 64 days from receipt to decision, against 135 for FDA’s reviews in the same codes and years. Its devices cite 11 predicates, 3 of them its own earlier devices. 15 recalls are 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 Japan Corporation’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2011: 12015: 12019: 12020: 12021: 12022: 22023: 12024: 12026 (partial year): 1
2011high 2 (2022) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

1in 2026

2012: 12013: 12014: 22016: 22019: 12020: 12021: 42024: 22026 (partial year): 1
2011high 4 (2021) · low 0 (2011)2026

Class I Class II/III not classified

FIG. 1 — Ge Healthcare Japan Corporation by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Ge Healthcare Japan Corporation’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?

  • JAKSystem, X-Ray, Tomography, Computed8decisions
  • LNHSystem, Nuclear Magnetic Resonance Imaging2decisions

How long do its 510(k) reviews take?

Since 2016, its 8 510(k)s took a median of 64 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 135 days; 7 of its 8 were faster than that.

Whose devices does it build on?

Its devices cite 11 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 10 times; 3 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.

  • K103327Discovery MR750W 3.0TGe Healthcare Japan Corporation · 20113cite it
  • K143345SIGNA PioneerGe Healthcare Japan Corporation · 20153cite it
  • K213938Revolution AscendGe Healthcare Japan Corporation · 20222cite it
  • K203169Revolution AscendGe Healthcare Japan Corporation · 20201cites it
  • K193170Deep Learning Image ReconstructionGe Healthcare Japan Corporation · 20191cites it

What has FDA decided for it lately?

  • K253686True Definition DLGe Healthcare Japan Corporation · 2026
  • K233698True Enhance DLGe Healthcare Japan Corporation · 2024
  • K230807Deep Learning Image ReconstructionGe Healthcare Japan Corporation · 2023
  • K220961Deep Learning Image ReconstructionGe Healthcare Japan Corporation · 2022
  • K213938Revolution AscendGe Healthcare Japan Corporation · 20222 recalls
  • K212067Deep Learning Image ReconstructionGe Healthcare Japan Corporation · 2021
  • K203169Revolution AscendGe Healthcare Japan Corporation · 20201 recall
  • K193170Deep Learning Image ReconstructionGe Healthcare Japan Corporation · 2019

All 10 as Ge Healthcare Japan Corporation →

What has been recalled?

15 recalls linked to its devices; the latest:

  • K213938Revolution Ascend, computed tomography, Model Numbers 6969000-100 and 6969000-300Mar 26, 2026Class II
  • K213938GE Healthcare Revolution Ascend, Model number 6969000-100; X-ray/computed tomography…Nov 5, 2024Class II
  • K153003SIGNA Pioneer, with affected software versions: PX25.0 to PX25.5, PX26.0, PX26.1, PX28.0…Jun 14, 2024Class II
  • K143345GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Pioneer…Dec 23, 2021Class II
  • K143345SIGNA Pioneer nuclear magnetic resonance imaging systemAug 26, 2021Class II
  • K203169The system is intended to produce cross-sectional images of the body by computer…Jun 30, 2021Class II