Toshiba America Medical Systems, In.C: FDA clearances and approvals
Toshiba America Medical Systems, In.C has 146 FDA 510(k) clearances (first 1989, latest 2014), across 30 product codes in 4 review panels. Median 510(k) review time: 47 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 6 | 146 |
| 2013 | 3 | 127 |
| 2014 | 3 | 108 |
| 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 |
|---|---|---|---|
| JAK | System, X-Ray, Tomography, Computed | 35 | 35 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 22 | 22 |
| JAA | System, X-Ray, Fluoroscopic, Image-Intensified | 13 | 13 |
| LLZ | System, Image Processing, Radiological | 10 | 10 |
| LNH | System, Nuclear Magnetic Resonance Imaging | 10 | 10 |
| ITX | Transducer, Ultrasonic, Diagnostic | 9 | 9 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 9 | 9 |
| KPS | System, Tomography, Computed, Emission | 6 | 6 |
| MQB | Solid State X-Ray Imager (Flat Panel/Digital Imager) | 5 | 5 |
| OWB | Interventional Fluoroscopic X-Ray System | 3 | 3 |
Plus 20 more product codes.
Review panels
- Radiology (143)
- Cardiovascular (1)
- General Hospital (1)
- Neurology (1)
Most recent Toshiba America Medical Systems, In.C 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K141472 | VANTAGE ELAN | LNH | 2014-09-19 | 108 |
| K133553 | KALARE | JAA | 2014-06-13 | 206 |
| K140729 | APLIO ARTIDA, V3.2 | IYN | 2014-05-23 | 60 |
| K132106 | INFINIX ANGIO WORKSTATION W/DTS SOFTWARE | JAA | 2013-11-12 | 127 |
| K131822 | ULTRAEXTEND USWS-900A V2.1 AND V3.1 | LLZ | 2013-07-23 | 33 |
| K123097 | DOSE TRACKING SYSTEM MODEL XIDF-DTS801 | JAA | 2013-02-13 | 134 |
| K122613 | VANTAGE TITAN WITH HELIOS GRADIENT MODEL MRT-1504/US | LNH | 2012-12-13 | 108 |
| K122842 | RADREX-I, SW V4.00 MODEL DRAD-3000E | MQB | 2012-10-09 | 22 |
| K121076 | ULTRAEXTEND FX, ULTRASOUND WORKSTATION PACKAGE | LLZ | 2012-10-09 | 183 |
| K122109 | AQUILION ONE VISION, V4.90 | JAK | 2012-09-21 | 66 |
136 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Toshiba America Medical Systems, In.C.
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 America Medical Systems, In.C'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 LNI)
Frequently asked questions
How many FDA 510(k) clearances does Toshiba America Medical Systems, In.C have?
Toshiba America Medical Systems, In.C has 146 FDA 510(k) clearances (first 1989, latest 2014), across 30 product codes in 4 review panels.
How long does FDA take to clear Toshiba America Medical Systems, In.C's 510(k)s?
The median time from FDA receipt to decision across Toshiba America Medical Systems, In.C's cleared 510(k)s is 47 days.
What devices does Toshiba America Medical Systems, In.C make?
Its most frequent FDA product codes are JAK (System, X-Ray, Tomography, Computed, 35); IYN (System, Imaging, Pulsed Doppler, Ultrasonic, 22); JAA (System, X-Ray, Fluoroscopic, Image-Intensified, 13).
Has Toshiba America Medical Systems, In.C had device recalls?
openFDA lists no recalls under a recalling firm name matching Toshiba America Medical Systems, In.C. Related entities may recall under other names.
Next steps
- See all 146 Toshiba America Medical Systems, In.C clearances with predicates and recalls
- Run predicate analysis for product code JAK, Toshiba America Medical Systems, In.C'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.