Toshiba America Mri, Inc.: FDA clearances and approvals
Toshiba America Mri, Inc. has 68 FDA 510(k) clearances (first 1990, latest 2000), across 2 product codes in 1 review panel. Median 510(k) review time: 88 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 |
|---|---|---|---|
| LNH | System, Nuclear Magnetic Resonance Imaging | 62 | 62 |
| MOS | Coil, Magnetic Resonance, Specialty | 6 | 6 |
Review panels
- Radiology (68)
Most recent Toshiba America Mri, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K002531 | EXCELART WITH PIANISSIMO, MODEL MRT-1501/P3 | LNH | 2000-10-26 | 71 |
| K002522 | OPART, MODEL MRT-600 | MOS | 2000-10-25 | 71 |
| K000549 | OPART, MODEL MRT-600 | MOS | 2000-04-20 | 62 |
| K993803 | EXCELART WITH PIANISSIMO | LNH | 2000-02-06 | 89 |
| K993574 | OPART/PRODIGA, OPART/PROTENZA, OPART/PARAGON | LNH | 2000-01-18 | 89 |
| K991740 | OPART, MODEL MRT-600 | MOS | 1999-08-02 | 73 |
| K991057 | EXTRA LARGE BODY COIL FOR OPART (MRT-600) | MOS | 1999-05-20 | 51 |
| K990620 | EXCELART | LNH | 1999-05-14 | 78 |
| K990260 | OPART | LNH | 1999-04-15 | 78 |
| K990007 | OPART, MODEL MRT-600 | MOS | 1999-04-01 | 87 |
58 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Toshiba America Mri, Inc..
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 Mri, Inc.'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 MOS)
Frequently asked questions
How many FDA 510(k) clearances does Toshiba America Mri, Inc. have?
Toshiba America Mri, Inc. has 68 FDA 510(k) clearances (first 1990, latest 2000), across 2 product codes in 1 review panel.
How long does FDA take to clear Toshiba America Mri, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Toshiba America Mri, Inc.'s cleared 510(k)s is 88 days.
What devices does Toshiba America Mri, Inc. make?
Its most frequent FDA product codes are LNH (System, Nuclear Magnetic Resonance Imaging, 62); MOS (Coil, Magnetic Resonance, Specialty, 6).
Has Toshiba America Mri, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Toshiba America Mri, Inc. Related entities may recall under other names.
Next steps
- See all 68 Toshiba America Mri, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LNH, Toshiba America Mri, Inc.'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.