Hitachi Aloka Medical, Ltd.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Hitachi Aloka Medical, Ltd.” (first 2012, latest 2015), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 56 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Fujifilm Healthcare, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 55 |
| 2013 | 2 | 47 |
| 2014 | 2 | 52 |
| 2015 | 1 | 142 |
| 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 |
|---|---|---|---|
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 5 | 5 |
| ITX | Transducer, Ultrasonic, Diagnostic | 1 | 1 |
Review panels
- Radiology (6)
Most recent Hitachi Aloka Medical, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K142368 | NOBLUS DIAGNOSTIC ULTRASOUND SCANNER | IYN | 2015-01-14 | 142 |
| K140854 | INTRA-OPERATIVE ULTRASOUND TRANSDUCER | ITX | 2014-06-11 | 69 |
| K140639 | PROSOUND F75 DIAGNOSTIC ULTRASOUND SYSTEM | IYN | 2014-04-16 | 35 |
| K130308 | NOBLUS ULTRASOUND DIAGNOSTIC SYSTEM | IYN | 2013-04-05 | 57 |
| K123828 | PROSOUND F75 DIAGNOSTIC ULTRASOUND SYSTEM | IYN | 2013-01-18 | 37 |
| K122341 | PROSOUND F37 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL: PROSOUND F37 | IYN | 2012-09-26 | 55 |
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2014-06-11.
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.
- 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 , Ltd. (8 510(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 Aloka Medical, Ltd.?
FDA lists 6 510(k) clearances under the applicant name “Hitachi Aloka Medical, Ltd.” (first 2012, latest 2015), across 2 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 Aloka Medical, Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Hitachi Aloka Medical, Ltd. is 56 days.
Which FDA product codes appear under Hitachi Aloka Medical, Ltd.?
The most frequent FDA product codes under this applicant name are IYN (System, Imaging, Pulsed Doppler, Ultrasonic, 5); ITX (Transducer, Ultrasonic, Diagnostic, 1).
Next steps
- See all 6 Hitachi Aloka Medical, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code IYN, Hitachi Aloka Medical, 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.