Toshiba Medical Systems: FDA clearances and approvals
Toshiba Medical Systems has 54 FDA 510(k) clearances (first 1977, latest 1996), across 19 product codes in 3 review panels. Median 510(k) review time: 81 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 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 |
|---|---|---|---|
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 12 | 12 |
| ITX | Transducer, Ultrasonic, Diagnostic | 9 | 9 |
| IYX | Camera, Scintillation (Gamma) | 5 | 5 |
| JAK | System, X-Ray, Tomography, Computed | 5 | 5 |
| DXK | Echocardiograph | 3 | 3 |
| JWM | System, Tomographic, Nuclear | 3 | 3 |
| FLL | Continuous Measurement Thermometer | 2 | 2 |
| IZF | System, X-Ray, Tomographic | 2 | 2 |
| IZO | Generator, High-Voltage, X-Ray, Diagnostic | 2 | 2 |
| LNH | System, Nuclear Magnetic Resonance Imaging | 2 | 2 |
Plus 9 more product codes.
Review panels
- Radiology (48)
- Cardiovascular (4)
- General Hospital (2)
Most recent Toshiba Medical Systems 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K960948 | SCATTER CORRECTION VOLUME SOFTWARE MODEL NSSC-020A | KPS | 1996-12-23 | 290 |
| K954310 | BLA-800A | KPW | 1995-10-18 | 33 |
| K954309 | ANGIOREX | IZI | 1995-10-06 | 21 |
| K893750 | MRT-50A MOBILE | LNH | 1989-08-09 | 83 |
| K891453 | DIAGNOSTIC ULTRASOUND TRANSDUCER: PVE-582V | IYO | 1989-06-01 | 78 |
| K890969 | TRANSESOPHAGEAL TRANSDUCER PEF-511SA | IYO | 1989-05-16 | 78 |
| K884788 | TOSHIBA TCT-600XT COMPUTED TOMOGRAPHY X-RAY SYSTEM | JAK | 1989-02-27 | 104 |
| K884555 | TCT-600HQ COMPU TOMO(CT)XRAY/HEAD/WHOLE BODY EXAM | JAK | 1989-02-27 | 119 |
| K883359 | DIAGNOSTIC ULTRASOUND SYSTEM SSA-270A | IYO | 1989-01-25 | 168 |
| K883756 | TOSHIBA MRT-50A MAGNETIC RESONANCE SYSTEM | LNH | 1988-11-14 | 69 |
44 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Toshiba Medical Systems.
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 Toshiba Medical Systems'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 Toshiba Medical Systems have?
Toshiba Medical Systems has 54 FDA 510(k) clearances (first 1977, latest 1996), across 19 product codes in 3 review panels.
How long does FDA take to clear Toshiba Medical Systems's 510(k)s?
The median time from FDA receipt to decision across Toshiba Medical Systems's cleared 510(k)s is 81 days.
What devices does Toshiba Medical Systems make?
Its most frequent FDA product codes are IYO (System, Imaging, Pulsed Echo, Ultrasonic, 12); ITX (Transducer, Ultrasonic, Diagnostic, 9); IYX (Camera, Scintillation (Gamma), 5).
Has Toshiba Medical Systems had device recalls?
openFDA lists no recalls under a recalling firm name matching Toshiba Medical Systems. Related entities may recall under other names.
Next steps
- See all 54 Toshiba Medical Systems clearances with predicates and recalls
- Run predicate analysis for product code IYO, Toshiba Medical Systems'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.