Toshibamedical Systems Corporation: FDA clearances and approvals
Toshibamedical Systems Corporation has 80 FDA 510(k) clearances (first 2004, latest 2018), across 9 product codes in 1 review panel. Median 510(k) review time: 92 days. Since 2017 its median was 106 days, against 110 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 8 | 74 |
| 2013 | 8 | 104 |
| 2014 | 12 | 111 |
| 2015 | 16 | 76 |
| 2016 | 11 | 102 |
| 2017 | 11 | 104 |
| 2018 | 5 | 107 |
| 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, Toshibamedical Systems Corporation's cleared 510(k)s took a median 106 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 110 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JAK | System, X-Ray, Tomography, Computed | 27 | 27 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 18 | 18 |
| LNH | System, Nuclear Magnetic Resonance Imaging | 14 | 14 |
| OWB | Interventional Fluoroscopic X-Ray System | 13 | 13 |
| LLZ | System, Image Processing, Radiological | 3 | 3 |
| KPS | System, Tomography, Computed, Emission | 2 | 2 |
| ITX | Transducer, Ultrasonic, Diagnostic | 1 | 1 |
| IZI | System, X-Ray, Angiographic | 1 | 1 |
| JAA | System, X-Ray, Fluoroscopic, Image-Intensified | 1 | 1 |
Review panels
- Radiology (80)
Most recent Toshibamedical Systems Corporation 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K173962 | Viamo c100 TUS-VC100 Diagnostic Ultrasound System | IYN | 2018-04-20 | 113 |
| K173468 | Aquilion Precision (TSX-304A/2) V8.6 with FIRST 3.0 | JAK | 2018-02-23 | 107 |
| K173088 | Vitrea Software Toshiba Package VSTP-001A | LLZ | 2018-01-31 | 124 |
| K173382 | Vantage Galan 3T, V4.6 | LNH | 2018-01-26 | 88 |
| K173090 | Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V2.4 | IYN | 2018-01-11 | 104 |
| K172863 | Infinix-i, INFX-8000V, V7.0 | OWB | 2017-12-14 | 85 |
| K172276 | Xario 200 Diagnostic Ultrasound System V6.0 | IYN | 2017-12-12 | 137 |
| K172646 | XIDF-AWS801, Angio Workstation, V7.0 | OWB | 2017-10-30 | 59 |
| K171597 | Vantage Elan 1.5T, V4.0 | LNH | 2017-07-21 | 51 |
| K170832 | Ultimax-i, DREX-UI80 V1.60 | OWB | 2017-07-21 | 123 |
70 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Toshibamedical Systems Corporation.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of Toshibamedical Systems Corporation's product codes (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 LNH)
Frequently asked questions
How many FDA 510(k) clearances does Toshibamedical Systems Corporation have?
Toshibamedical Systems Corporation has 80 FDA 510(k) clearances (first 2004, latest 2018), across 9 product codes in 1 review panel.
How long does FDA take to clear Toshibamedical Systems Corporation's 510(k)s?
The median time from FDA receipt to decision across Toshibamedical Systems Corporation's cleared 510(k)s is 92 days. Since 2017: 106 days, versus 110 days for all cleared 510(k)s in the same product codes.
What devices does Toshibamedical Systems Corporation make?
Its most frequent FDA product codes are JAK (System, X-Ray, Tomography, Computed, 27); IYN (System, Imaging, Pulsed Doppler, Ultrasonic, 18); LNH (System, Nuclear Magnetic Resonance Imaging, 14).
Has Toshibamedical Systems Corporation had device recalls?
openFDA lists no recalls under a recalling firm name matching Toshibamedical Systems Corporation. Related entities may recall under other names.
Next steps
- See all 80 Toshibamedical Systems Corporation clearances with predicates and recalls
- Run predicate analysis for product code JAK, Toshibamedical Systems Corporation's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.