Toshiba Medical Systems Coporation, Japan: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Toshiba Medical Systems Coporation, Japan” (first 2011, latest 2012), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 67 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 | 2 | 117 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MOS | Coil, Magnetic Resonance, Specialty | 2 | 2 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 1 | 1 |
| JAA | System, X-Ray, Fluoroscopic, Image-Intensified | 1 | 1 |
| JAK | System, X-Ray, Tomography, Computed | 1 | 1 |
Review panels
- Radiology (5)
Most recent Toshiba Medical Systems Coporation, Japan 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K121422 | APLIO 500/400/300 DIAGNOSTIC ULTRASOUND SYSTEM | IYO | 2012-08-16 | 94 |
| K113466 | AQUILION ONE | JAK | 2012-04-10 | 140 |
| K112366 | 4CH FLEX SPEEDER | MOS | 2011-09-15 | 29 |
| K111251 | 4CH FLEX SPEEDER | MOS | 2011-05-27 | 23 |
| K110785 | KALARE DIAGNOSTIC X-RAY TABLE SYSTEM | JAA | 2011-05-27 | 67 |
Recalls
openFDA lists no recalls under a recalling firm named Toshiba Medical Systems Coporation, 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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Toshiba Medical Systems Coporation, Japan (a text match, not an official crosswalk):
- C8900 — Magnetic resonance angiography with contrast, abdomen (via MOS)
- C8901 — Magnetic resonance angiography without contrast, abdomen (via MOS)
- C8918 — Magnetic resonance angiography with contrast, pelvis (via MOS)
- C8919 — Magnetic resonance angiography without contrast, pelvis (via MOS)
- C8902 — Magnetic resonance angiography without contrast followed by 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 Corporation, Japan (9 510(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 Coporation, Japan?
FDA lists 5 510(k) clearances under the applicant name “Toshiba Medical Systems Coporation, Japan” (first 2011, latest 2012), across 4 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 Coporation, Japan?
The median time from FDA receipt to decision across 510(k)s cleared under the name Toshiba Medical Systems Coporation, Japan is 67 days.
Which FDA product codes appear under Toshiba Medical Systems Coporation, Japan?
The most frequent FDA product codes under this applicant name are MOS (Coil, Magnetic Resonance, Specialty, 2); IYO (System, Imaging, Pulsed Echo, Ultrasonic, 1); JAA (System, X-Ray, Fluoroscopic, Image-Intensified, 1).
Next steps
- See all 5 Toshiba Medical Systems Coporation, Japan clearances with predicates and recalls
- Run predicate analysis for product code MOS, Toshiba Medical Systems Coporation, 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.