Hitachi Medical Corp. of America: FDA clearances and approvals
Hitachi Medical Corp. of America has 32 FDA 510(k) clearances (first 1985, latest 2000), across 8 product codes in 3 review panels. Median 510(k) review time: 168 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 |
|---|---|---|---|
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 12 | 12 |
| ITX | Transducer, Ultrasonic, Diagnostic | 6 | 6 |
| KPS | System, Tomography, Computed, Emission | 5 | 5 |
| DXK | Echocardiograph | 4 | 4 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 2 | 2 |
| HGL | Transducer, Ultrasonic, Obstetric | 1 | 1 |
| IZI | System, X-Ray, Angiographic | 1 | 1 |
| JAF | Monitor, Ultrasonic, Nonfetal | 1 | 1 |
Review panels
- Radiology (27)
- Cardiovascular (4)
- Obstetrics and Gynecology (1)
Most recent Hitachi Medical Corp. of America 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K994026 | EUB-6000 ULTRASOUND DIAGNOSTIC SCANNER | IYN | 2000-03-29 | 124 |
| K991535 | CONVERGENCE CDR FOR HITACHI SPECTRADIGITAL V250DSP GAMMA CAMERAS | KPS | 1999-07-30 | 88 |
| K991318 | CONVERGENCE NUA FOR HITACHI SPECTRADIGITAL V250DSP GAMMA CAMERAS | KPS | 1999-06-18 | 60 |
| K991129 | HITACHI SPECTRADIGITAL V250DSP GAMMA CAMERA SYSTEM WITH THICK NAL(TI) CRYSTAL | KPS | 1999-05-13 | 41 |
| K981434 | EUP-OL334 LAPARASCOPICPROBE | ITX | 1998-07-27 | 97 |
| K954220 | EUB-8000 | IYN | 1997-05-07 | 604 |
| K962308 | EUB-905 | IYO | 1996-07-17 | 30 |
| K954143 | HITACHI SPECTRADIGITAL SERIES GAMMA CAMERA SYSTEMS | KPS | 1995-12-22 | 112 |
| K954129 | SPECTRADIGITAL SERIES V250DSP | KPS | 1995-12-22 | 112 |
| K945400 | HITACHI DYNAMIC 3D IMAGING SYSTEM,SF-VA100 | IZI | 1995-11-20 | 382 |
22 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Hitachi Medical Corp. of America.
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.
Frequently asked questions
How many FDA 510(k) clearances does Hitachi Medical Corp. of America have?
Hitachi Medical Corp. of America has 32 FDA 510(k) clearances (first 1985, latest 2000), across 8 product codes in 3 review panels.
How long does FDA take to clear Hitachi Medical Corp. of America's 510(k)s?
The median time from FDA receipt to decision across Hitachi Medical Corp. of America's cleared 510(k)s is 168 days.
What devices does Hitachi Medical Corp. of America make?
Its most frequent FDA product codes are IYO (System, Imaging, Pulsed Echo, Ultrasonic, 12); ITX (Transducer, Ultrasonic, Diagnostic, 6); KPS (System, Tomography, Computed, Emission, 5).
Has Hitachi Medical Corp. of America had device recalls?
openFDA lists no recalls under a recalling firm name matching Hitachi Medical Corp. of America. Related entities may recall under other names.
Next steps
- See all 32 Hitachi Medical Corp. of America clearances with predicates and recalls
- Run predicate analysis for product code IYO, Hitachi Medical Corp. of America'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.