510(k) Report

FDA applicant

Toshiba Medical Systems Corporation, Japan

Tustin, CA9 decisions2011–20174 recalls

FDA records 9 decisions for Toshiba Medical Systems Corporation, Japan (Tustin, CA) from 2011 to 2017: 9 510(k) clearances. Most are in product codes LNH (System, Nuclear Magnetic Resonance Imaging) and JAK (System, X-Ray, Tomography, Computed). Its devices cite 10 predicates, 0 of them its own earlier devices. 4 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 Corporation, Japan’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2011: 32012: 42014: 12017: 1
2011high 4 (2012) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

1in 2021

2013: 12015: 12019: 12021: 1
2011high 1 (2013) · low 0 (2011)2026

Class I Class II/III not classified

FIG. 1 — Toshiba Medical Systems Corporation, Japan by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

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Which product codes does it file in?

  • LNHSystem, Nuclear Magnetic Resonance Imaging2decisions
  • JAKSystem, X-Ray, Tomography, Computed2decisions
  • MOSCoil, Magnetic Resonance, Specialty2decisions
  • IYNSystem, Imaging, Pulsed Doppler, Ultrasonic1decision
  • ITXTransducer, Ultrasonic, Diagnostic1decision
  • JAASystem, X-Ray, Fluoroscopic, Image-Intensified1decision

Whose devices does it build on?

Its devices cite 10 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 times; 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.

  • K102489Vantage Titan 3TToshiba Medical Systems Corporation, Japan · 20112cite it
  • K121577Aplio Artida Diagnostic Ultrasound SystemToshiba Medical Systems Corporation, Japan · 20121cites it
  • K103645Aplio XG Diagnostic Ultrasound SystemToshiba Medical Systems Corporation, Japan · 20111cites it

What has FDA decided for it lately?

  • K172878Vantage Titan 3T, MRT-3010/A7, M-Power GXToshiba Medical Systems Corporation, Japan · 20171 recall
  • K133324Suresubtraction LungToshiba Medical Systems Corporation, Japan · 2014
  • K121911Octave Speeder SpineToshiba Medical Systems Corporation, Japan · 2012
  • K121910Octave Speeder HeadToshiba Medical Systems Corporation, Japan · 2012
  • K121577Aplio Artida Diagnostic Ultrasound SystemToshiba Medical Systems Corporation, Japan · 2012
  • K120546Aquilion PremiumToshiba Medical Systems Corporation, Japan · 20122 recalls
  • K112054Infinix CF-I/SP and Infinix VF-I/SP Model Infx-8000VToshiba Medical Systems Corporation, Japan · 2011
  • K102489Vantage Titan 3TToshiba Medical Systems Corporation, Japan · 20111 recall

All 9 as Toshiba Medical Systems Corporation, Japan →

What has been recalled?

4 recalls linked to its devices; the latest:

  • K172878Canon Vantage Titan 3T, Premium Open-Bore MRI System, REF: MRT-3010 - Product Usage: use…May 21, 2021Class II
  • K120546Canon Aquilion Premium, Model TSX-301BMar 25, 2019Class II
  • K120546Toshiba Aquilion CT System TSX-301BMay 8, 2015Class II
  • K102489Titan 3T MRI System, MRT-3010A/5. Product Usage: Usage: MRI system.Oct 28, 2013Class 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 Coporation, Japan 5Toshiba Medical Systems Coroporation 2Toshiba America Electronic Components, Inc. 1Toshiba Glass Co., Ltd. 1