Hitachi , Ltd.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Hitachi , Ltd.” (first 2006, latest 2020), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 76 days. Since 2017 the median was 96 days, against 102 days for all cleared 510(k)s in the same product codes. 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 | 3 | 63 |
| 2017 | 2 | 138 |
| 2018 | 0 | — |
| 2019 | 1 | 72 |
| 2020 | 1 | 84 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Hitachi , Ltd. took a median 96 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 102 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LHN | System, Radiation Therapy, Charged-Particle, Medical | 4 | 4 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 3 | 3 |
| MOT | Irradiator, Blood To Prevent Graft Versus Host Disease | 1 | 1 |
Review panels
- Radiology (8)
Most recent Hitachi , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K201042 | PROBEAT-CR | LHN | 2020-07-13 | 84 |
| K191801 | PROBEAT-CR | LHN | 2019-09-13 | 72 |
| K172087 | SANGRAY | MOT | 2017-10-27 | 108 |
| K163505 | ARIETTA PRECISION | IYN | 2017-05-30 | 167 |
| K162902 | ARIETTA Prologue Diagnostic Ultrasound system and Transducers | IYN | 2016-12-15 | 59 |
| K162583 | ALOKA LISENDO 880 | IYN | 2016-11-17 | 63 |
| K161163 | PROBEAT-V Proton Beam Therapy System with X-ray Limiting Accessory | LHN | 2016-07-13 | 79 |
| K060834 | PROBEAT WITH MGCS | LHN | 2006-04-19 | 23 |
Recalls
openFDA lists no recalls under a recalling firm named Hitachi , Ltd..
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.
SEC filings
HITACHI LTD (HTHIF, HTHIY): EDGAR filings, CIK 47710. An SEC registrant with the same name, matched by name only.
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.
- Hitachi Medical Systems America, Inc. (100 510(k)s)
- Hitachi Medical Corp. of America (32 510(k)s)
- Hitachi Healthcare Americas (17 510(k)s)
- Hitachi Chemical Diagnostics, Inc. (16 510(k)s)
- Hitachi Medical Corp. (12 510(k)s)
- Hitachi Aloka Medical, Ltd. (6 510(k)s)
- Hitachi, Ltd., Health Care Company (4 510(k)s)
- Hitachi Aloka Medical America, Inc. (3 510(k)s)
- Hitachi Aloka Medical,Ltd. (Hitachi Aloka Medical (3 510(k)s)
- Hitachi, Ltd., Power Systems Group (2 510(k)s)
- Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha (2 510(k)s)
- Hitachi Sales Corporation of America (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Hitachi , Ltd.?
FDA lists 8 510(k) clearances under the applicant name “Hitachi , Ltd.” (first 2006, latest 2020), across 3 product codes 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 Hitachi , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Hitachi , Ltd. is 76 days. Since 2017: 96 days, versus 102 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Hitachi , Ltd.?
The most frequent FDA product codes under this applicant name are LHN (System, Radiation Therapy, Charged-Particle, Medical, 4); IYN (System, Imaging, Pulsed Doppler, Ultrasonic, 3); MOT (Irradiator, Blood To Prevent Graft Versus Host Disease, 1).
Next steps
- See all 8 Hitachi , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code LHN, Hitachi , Ltd.'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.