510(k) Report

FDA applicant

Canon Medical Systems, USA

Otawara-Shi, JP1 decision2018–20180 recalls

FDA records 1 decision for Canon Medical Systems, USA (Otawara-Shi, JP) in 2018: 1 510(k) clearance. All are in product code JAK (System, X-Ray, Tomography, Computed). Its devices cite 1 predicate, 0 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 Canon Medical Systems, USA’s devices, and how often a recall has named them.

FDA decisions per year

1in 2018

2018: 1
2018high 1 (2018) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2018.

FIG. 1 — Canon Medical Systems, USA by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • JAKSystem, X-Ray, Tomography, Computed1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 0 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.

  • K182223Aquilion ONE Self-Propelled Scan Base Kit for IVR-CT, CGBA-034ACanon Medical Systems, USA · 20181cites it

What has FDA decided for it lately?

  • K182223Aquilion ONE Self-Propelled Scan Base Kit for IVR-CT, CGBA-034ACanon Medical Systems, USA · 2018

The one decision as Canon Medical Systems, USA →

Other applicant names beginning “Canon”

FDA records each applicant name separately; these may or may not be the same firm.

Canon Medical Systems Corporation 97Canon USA, Inc. 48Canon, Inc. 43Canon Inc. -Medical Equipment Group 11Canon Medical Informatics, Inc. 5Canon, Inc. - Medical Equpment Group 1Canon Components, Inc. 1Canon, Inc.-Utsunomiya Optical Products Operation 1