510(k) Report

FDA applicant

Toshiba Medical Systems Coroporation

Otawara-Shi, JP2 decisions2017–20176 recalls

FDA records 2 decisions for Toshiba Medical Systems Coroporation (Otawara-Shi, JP) in 2017: 2 510(k) clearances. Most are in product codes JAK (System, X-Ray, Tomography, Computed) and OWB (Interventional Fluoroscopic X-Ray System). Its devices cite 3 predicates, 0 of them its own earlier devices. 6 recalls are 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 Toshiba Medical Systems Coroporation’s devices, and how often a recall has named them.

FDA decisions per year

2in 2017

2017: 2
2017high 2 (2017) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

1in 2022

2017: 12019: 12020: 22021: 12022: 1
2017high 2 (2020) · low 0 (2018)2026

Class I Class II/III not classified

FIG. 1 — Toshiba Medical Systems Coroporation by year, 2017–2026Sources: 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
  • OWBInterventional Fluoroscopic X-Ray System1decision

Whose devices does it build on?

Its devices cite 3 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.

  • K172188Aquilion Prime SP, TSX-303B/1, v8.4Toshiba Medical Systems Coroporation · 20171cites it

What has FDA decided for it lately?

  • K172188Aquilion Prime SP, TSX-303B/1, v8.4Toshiba Medical Systems Coroporation · 20171 recall
  • K170909Infinix INFX-8000V, V6.40Toshiba Medical Systems Coroporation · 20175 recalls

All 2 as Toshiba Medical Systems Coroporation →

What has been recalled?

6 recalls linked to its devices; the latest:

  • K170909INFX-8000V. For radiographic and fluoroscopic studies and intervention.Jan 31, 2022Class II
  • K170909System INFX-8000VFeb 5, 2021Class II
  • K170909Canon INTERVENTIONAL ANGIOGRAPHY SYSTEM MODEL INFX-8000V Catheterization Table CAT-880B…Dec 8, 2020Class II
  • K170909Infinix-8000V with Catheterization Table CAT-850B or CAT-860B - Product Usage: This…Mar 3, 2020Class II
  • K172188Canon Aquilion Prime SP, Model TSX-303BMar 25, 2019Class II
  • K170909INFX-8000V Fluoroscopic X-Ray Systems; INFINIX CF-I/BP PLUS CARDIAC SYSTEMDec 29, 2017Class II

Other applicant names beginning “Toshiba”

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

Toshiba America Medical Systems, In.C 146Toshiba America Mri, Inc. 68Toshiba Medical Systems 54Toshiba Medical Systems Corporation, Japan 9Toshiba Medical Systems Coporation, Japan 5Toshiba America Electronic Components, Inc. 1Toshiba Glass Co., Ltd. 1