Hitachi Healthcare Americas: FDA filings under this applicant name
FDA lists 17 510(k) clearances under the applicant name “Hitachi Healthcare Americas” (first 2017, latest 2021), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 91 days. Since 2017 the median was 91 days, against 116 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.
Caduvo groups this applicant name under Fujifilm Healthcare, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2017 | 2 | 106 |
| 2018 | 5 | 83 |
| 2019 | 5 | 67 |
| 2020 | 4 | 116 |
| 2021 | 1 | 154 |
| 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 Healthcare Americas took a median 91 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 116 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 7 | 7 |
| JAK | System, X-Ray, Tomography, Computed | 5 | 5 |
| LNH | System, Nuclear Magnetic Resonance Imaging | 4 | 4 |
| DQA | Oximeter | 1 | 1 |
Review panels
- Radiology (16)
- Anesthesiology (1)
Most recent Hitachi Healthcare Americas 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K211406 | OASIS MRI System | LNH | 2021-10-07 | 154 |
| K202422 | Arietta 65 | IYN | 2020-11-04 | 72 |
| K202030 | OASIS MRI System | LNH | 2020-10-21 | 91 |
| K200498 | SCENARIA View | JAK | 2020-07-17 | 140 |
| K192851 | OASIS MRI System | LNH | 2020-02-21 | 141 |
| K190841 | SCENARIA View | JAK | 2019-09-13 | 165 |
| K191233 | ARIETTA 750 | IYN | 2019-08-09 | 93 |
| K190248 | ARIETTA 50 | IYN | 2019-04-02 | 54 |
| K183291 | Supria True64 Whole-Body X-Ray CT System | JAK | 2019-02-01 | 67 |
| K183456 | Aloka Arietta 850 | IYN | 2019-01-28 | 46 |
7 earlier clearances. See the full list in Caduvo.
Recalls
4 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2021-07-29.
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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Hitachi Healthcare Americas (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 LNH)
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 Chemical Diagnostics, Inc. (16 510(k)s)
- Hitachi Medical Corp. (12 510(k)s)
- Hitachi , Ltd. (8 510(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 Healthcare Americas?
FDA lists 17 510(k) clearances under the applicant name “Hitachi Healthcare Americas” (first 2017, latest 2021), across 4 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Hitachi Healthcare Americas?
The median time from FDA receipt to decision across 510(k)s cleared under the name Hitachi Healthcare Americas is 91 days. Since 2017: 91 days, versus 116 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Hitachi Healthcare Americas?
The most frequent FDA product codes under this applicant name are IYN (System, Imaging, Pulsed Doppler, Ultrasonic, 7); JAK (System, X-Ray, Tomography, Computed, 5); LNH (System, Nuclear Magnetic Resonance Imaging, 4).
Next steps
- See all 17 Hitachi Healthcare Americas clearances with predicates and recalls
- Run predicate analysis for product code IYN, Hitachi Healthcare Americas'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.