510(k) Report

FDA applicant

Anzai Medical Co., Ltd.

Brookeville, MD4 decisions2002–20170 recalls

FDA records 4 decisions for Anzai Medical Co., Ltd. (Brookeville, MD) from 2002 to 2017: 4 510(k) clearances. Most are in product codes LHN (System, Radiation Therapy, Charged-Particle…) and IYX (Camera, Scintillation (Gamma)). Its devices cite 4 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 Anzai Medical Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2016: 12017: 1
2007high 1 (2016) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Anzai Medical Co., Ltd. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Anzai Medical Co., Ltd.’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?

  • LHNSystem, Radiation Therapy, Charged-Particle, Medical3decisions
  • IYXCamera, Scintillation (Gamma)1decision

Whose devices does it build on?

Its devices cite 4 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 6 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.

  • K022342EZ-Scope an, EZ-Scope LightAnzai Medical Co., Ltd. · 20022cite it
  • K031385Anzai AZ-733 Respiratory Gating SystemAnzai Medical Co., Ltd. · 20032cite it
  • K160432Anzai Respiratory Gating SystemAnzai Medical Co., Ltd. · 20161cites it
  • K170719Anzai Respiratory Gating SystemAnzai Medical Co., Ltd. · 20171cites it

What has FDA decided for it lately?

  • K170719Anzai Respiratory Gating SystemAnzai Medical Co., Ltd. · 2017
  • K160432Anzai Respiratory Gating SystemAnzai Medical Co., Ltd. · 2016
  • K031385Anzai AZ-733 Respiratory Gating SystemAnzai Medical Co., Ltd. · 2003
  • K022342EZ-Scope an, EZ-Scope LightAnzai Medical Co., Ltd. · 2002

All 4 as Anzai Medical Co., Ltd. →