Mitsubishi Intl. Corp.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Mitsubishi Intl. Corp.” (first 1988, latest 1996), across 1 product code in 1 review panel. Median 510(k) review time under this name: 230 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
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 |
|---|---|---|---|
| IYE | Accelerator, Linear, Medical | 5 | 5 |
Review panels
- Radiology (5)
Most recent Mitsubishi Intl. Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K961214 | MULTI LEAF COLLIMATOR | IYE | 1996-08-06 | 131 |
| K952314 | EXL-12SP & 12DP LINAC | IYE | 1996-01-17 | 245 |
| K952108 | EXL-15DP & 20-DP LINAC | IYE | 1995-12-21 | 230 |
| K880200 | EXL-14 MEDICAL LINEAR ACCELERATOR | IYE | 1988-08-04 | 206 |
| K873398 | EXL-22DP X-RAY RADIATION THERAPY SYSTEM | IYE | 1988-04-29 | 249 |
Recalls
openFDA lists no recalls under a recalling firm named Mitsubishi Intl. Corp..
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.
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.
- Mitsubishi Kagaku Iatron (4 510(k)s)
- Mitsubishi Cable America, Inc. (3 510(k)s)
- Mitsubishi Chemical Medience Corporation (3 510(k)s)
- Mitsubishi Electronics America, Inc. (3 510(k)s)
- Mitsubishi Heavy Industries, Ltd. (3 510(k)s)
- Mitsubishi Yuka America, Inc. (2 510(k)s)
- Mitsubishi Electric Corporation Kyoto Works (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Mitsubishi Intl. Corp.?
FDA lists 5 510(k) clearances under the applicant name “Mitsubishi Intl. Corp.” (first 1988, latest 1996), across 1 product code 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 Mitsubishi Intl. Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Mitsubishi Intl. Corp. is 230 days.
Which FDA product codes appear under Mitsubishi Intl. Corp.?
The most frequent FDA product codes under this applicant name are IYE (Accelerator, Linear, Medical, 5).
Next steps
- See all 5 Mitsubishi Intl. Corp. clearances with predicates and recalls
- Run predicate analysis for product code IYE, Mitsubishi Intl. Corp.'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.