510(k) Report

FDA applicant

Shimadzu Corporation Medical Systems Division

Kyoto, JP2 decisions2022–20241 recall

FDA records 2 decisions for Shimadzu Corporation Medical Systems Division (Kyoto, JP) from 2022 to 2024: 2 510(k) clearances. Most are in product codes OWB (Interventional Fluoroscopic X-Ray System) and KPS (System, Tomography, Computed, Emission). Its devices cite 2 predicates, 0 of them its own earlier devices. 1 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 Shimadzu Corporation Medical Systems Division’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2022: 12024: 1
2022high 1 (2022) · low 0 (2023)2026

2026 so far, outlined.

Recalls per year

1in 2026

2026 (partial year): 1
2022high 1 (2026) · low 0 (2022)2026

Class I Class II/III not classified

FIG. 1 — Shimadzu Corporation Medical Systems Division by year, 2022–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • OWBInterventional Fluoroscopic X-Ray System1decision
  • KPSSystem, Tomography, Computed, Emission1decision

Whose devices does it build on?

Its devices cite 2 predicates; 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.

  • K221922TriniasShimadzu Corporation Medical Systems Division · 20221cites it

What has FDA decided for it lately?

  • K240827SET-5002Shimadzu Corporation Medical Systems Division · 2024
  • K221922TriniasShimadzu Corporation Medical Systems Division · 20221 recall

All 2 as Shimadzu Corporation Medical Systems Division →

What has been recalled?

1 recall linked to its devices; the latest:

  • K062360Digital Angiography System Trinias:UD150G-40 / D150GC-40; Digital Angiography System…Apr 20, 2026Class II

Other applicant names beginning “Shimadzu”

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

Shimadzu Medical Systems 91Shimadzu Corp. 58Shimadzu Precision Instruments, Inc. 23