Toshiba Medical Systems Corporation, Japan: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Toshiba Medical Systems Corporation, Japan” (first 2011, latest 2017), across 6 product codes in 1 review panel. Median 510(k) review time under this name: 49 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Canon Medical Systems, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 4 | 49 |
| 2013 | 0 | — |
| 2014 | 1 | 311 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 1 | 57 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Toshiba Medical Systems Corporation, Japan took a median 57 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 105 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JAK | System, X-Ray, Tomography, Computed | 2 | 2 |
| LNH | System, Nuclear Magnetic Resonance Imaging | 2 | 2 |
| MOS | Coil, Magnetic Resonance, Specialty | 2 | 2 |
| ITX | Transducer, Ultrasonic, Diagnostic | 1 | 1 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 1 | 1 |
| JAA | System, X-Ray, Fluoroscopic, Image-Intensified | 1 | 1 |
Review panels
- Radiology (9)
Most recent Toshiba Medical Systems Corporation, Japan 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K172878 | Vantage Titan 3T, MRT-3010/A7, M-Power GX | LNH | 2017-11-17 | 57 |
| K133324 | SURESUBTRACTION LUNG | JAK | 2014-09-05 | 311 |
| K121911 | OCTAVE SPEEDER SPINE | MOS | 2012-08-17 | 49 |
| K121910 | OCTAVE SPEEDER HEAD | MOS | 2012-08-17 | 49 |
| K121577 | APLIO ARTIDA DIAGNOSTIC ULTRASOUND SYSTEM | IYN | 2012-06-22 | 23 |
| K120546 | AQUILION PREMIUM | JAK | 2012-06-13 | 111 |
| K112054 | INFINIX CF-I/SP AND INFINIX VF-I/SP MODEL INFX-8000V | JAA | 2011-08-05 | 17 |
| K102489 | VANTAGE TITAN 3T | LNH | 2011-08-02 | 336 |
| K103645 | APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM | ITX | 2011-01-12 | 30 |
Recalls
openFDA lists no recalls under a recalling firm named Toshiba Medical Systems Corporation, Japan.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Toshiba Medical Systems Corporation, Japan is the lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT03055780: Diagnostic Accuracy to Detect Hemodynamically Significant Stenosis by Non-invasive SURECardio CT-FFR (Completed, started 2015-07-01)
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Toshiba Medical Systems Corporation, Japan (a text match, not an official crosswalk):
- C8903 — Magnetic resonance imaging with contrast, breast; unilateral (via LNH)
- C8906 — Magnetic resonance imaging with contrast, breast; bilateral (via LNH)
- C8905 — Magnetic resonance imaging without contrast followed by with contrast, breast; unilateral (via LNH)
- C8908 — Magnetic resonance imaging without contrast followed by with contrast, breast; bilateral (via LNH)
- C8900 — Magnetic resonance angiography with contrast, abdomen (via MOS)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Toshiba America Medical Systems, In.C (146 510(k)s)
- Toshiba America Mri, Inc. (68 510(k)s)
- Toshiba Medical Systems (54 510(k)s)
- Toshiba Medical Systems Coporation, Japan (5 510(k)s)
- Toshiba Medical Systems Coroporation (2 510(k)s)
- Toshiba America Electronic Components, Inc. (1 510(k)s)
- Toshiba Glass Co., Ltd. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Toshiba Medical Systems Corporation, Japan?
FDA lists 9 510(k) clearances under the applicant name “Toshiba Medical Systems Corporation, Japan” (first 2011, latest 2017), across 6 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Toshiba Medical Systems Corporation, Japan?
The median time from FDA receipt to decision across 510(k)s cleared under the name Toshiba Medical Systems Corporation, Japan is 49 days.
Which FDA product codes appear under Toshiba Medical Systems Corporation, Japan?
The most frequent FDA product codes under this applicant name are JAK (System, X-Ray, Tomography, Computed, 2); LNH (System, Nuclear Magnetic Resonance Imaging, 2); MOS (Coil, Magnetic Resonance, Specialty, 2).
Next steps
- See all 9 Toshiba Medical Systems Corporation, Japan clearances with predicates and recalls
- Run predicate analysis for product code JAK, Toshiba Medical Systems Corporation, Japan's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.