510(k) Report

FDA applicant

Canon Inc. -Medical Equipment Group

Tachikawa-Shi, Tokyo, JP11 decisions2010–20181 recall

FDA records 11 decisions for Canon Inc. -Medical Equipment Group (Tachikawa-Shi, Tokyo, JP) from 2010 to 2018: 11 510(k) clearances. Most are in product codes MQB (Solid State X-Ray Imager (Flat Panel/Digital…) and HKI (Camera, Ophthalmic, Ac-Powered). Its devices cite 20 predicates, 6 of them its own earlier devices. 1 recall is linked to its devices.

FDA’s records also spell it “Canon, Inc. – Medical Equipment Group”.

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 Inc. -Medical Equipment Group’s devices, and how often a recall has named them.

FDA decisions per year

1in 2018

2010: 22011: 42012: 22013: 12017: 12018: 1
2010high 4 (2011) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

1in 2010

2010: 1
2010high 1 (2010) · low 0 (2011)2026

Class I Class II/III not classified

FIG. 1 — Canon Inc. -Medical Equipment Group by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Canon Inc. -Medical Equipment Group’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)6decisions
  • HKICamera, Ophthalmic, Ac-Powered2decisions
  • NFJSystem, Image Management, Ophthalmic1decision
  • OXOImage-Intensified Fluoroscopic X-Ray System, Mobile1decision
  • HKXTonometer, Ac-Powered1decision

Whose devices does it build on?

Its devices cite 20 predicates; 6 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 23 times; 6 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.

  • K102012Digital RadiographyCanon Inc. -Medical Equipment Group · 20106cite it
  • K103591Digital RadiographyCanon Inc. -Medical Equipment Group · 20114cite it
  • K111824Flat Panel DetectorCanon Inc. -Medical Equipment Group · 20123cite it
  • K112309Digital RadiographyCanon Inc. -Medical Equipment Group · 20112cite it
  • K123208Digital Retinal CameraCanon Inc. -Medical Equipment Group · 20132cite it
  • K173689Ophthalmic Software Platform RXCanon Inc. -Medical Equipment Group · 20182cite it

What has FDA decided for it lately?

  • K173689Ophthalmic Software Platform RXCanon Inc. -Medical Equipment Group · 2018
  • K162909CSX-30 Flat Panel DetectorCanon, Inc. – Medical Equipment Group · 2017
  • K123208Digital Retinal CameraCanon Inc. -Medical Equipment Group · 2013
  • K121303Mobile C-ArmCanon Inc. -Medical Equipment Group · 2012
  • K111824Flat Panel DetectorCanon Inc. -Medical Equipment Group · 2012
  • K111710Full Auto Tonometer Model TX-20Canon Inc. -Medical Equipment Group · 2011
  • K112309Digital RadiographyCanon Inc. -Medical Equipment Group · 2011
  • K111682Digital RadiographyCanon Inc. -Medical Equipment Group · 2011

All 10 as Canon Inc. -Medical Equipment Group →The one decision as Canon, Inc. – Medical Equipment Group →

What has been recalled?

1 recall linked to its devices; the latest:

  • K091435Canon Solid State X-ray Imager (Flat Panel/Digital Imager), Digital Radiography, Models…Nov 1, 2010Class II

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 Medical Informatics, Inc. 5Canon, Inc. - Medical Equpment Group 1Canon Components, Inc. 1Canon Medical Systems, USA 1Canon, Inc.-Utsunomiya Optical Products Operation 1