Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in JapanLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 4 spellings of its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list Canon and its 21 subsidiaries with 693 510(k) clearances, 119 device recalls, 51 AI-enabled devices and 1 drug application. The most recent is an AI-enabled device dated May 22, 2026: Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) Planning.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, Canon and its 21 subsidiaries
A hatched bar is a year that is not over, so its count covers only part of the year.
| Date | Record | Source |
|---|---|---|
| May 22, 2026 | Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) PlanningK260324 · Radiology | AI-enabled devices |
| May 20, 2026 | Aquilion ONE (TSX-308A/TSX-306A) V2.0K253596 · Radiology | AI-enabled devices |
| Apr 30, 2026 | Intelligent NRK252503 · Radiology | AI-enabled devices |
| Mar 27, 2026 | Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MRK253625 · Radiology | AI-enabled devices |
| Mar 13, 2026 | Aquilion ServeSP (TSX-307B) V2.0K260078 · Radiology | AI-enabled devices |
| Mar 10, 2026 | Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV Extension)K253584 · Radiology | AI-enabled devices |
| Dec 1, 2025 | Cartesion Prime (PCD-1000A/3) V10.21K251370 · Radiology | AI-enabled devices |
| Nov 28, 2025 | CT VScore+K252217 · Radiology | AI-enabled devices |
| Aug 10, 2023 | Functional MR V1.0Class II · When exporting regions of interest in DICOM SEGMENTATION format, when simultaneously exporting multiple volumes of inter | Device recalls |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
