Hitachi Healthcare Americas Corporation
FDA Regulatory Profile
Summary
- Total Recalls
- 4
- 510(k) Clearances
- 5
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2339-2021 | Class II | OASIS MRI System | July 29, 2021 |
| Z-2337-2021 | Class II | ECHELON MRI System | July 29, 2021 |
| Z-2338-2021 | Class II | ECHELON Oval MRI System | July 29, 2021 |
| Z-2308-2021 | Class II | Model L43K Intraoperative Probe-For the diagnostic ultrasound evaluation during robotic/non-robotic | June 30, 2021 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K181376 | ARIETTA 65 | July 18, 2018 |
| K173739 | ALOKA ARIETTA 850 | February 28, 2018 |
| K172110 | ECHELON OVAL V6.0A MRI System | January 11, 2018 |
| K171708 | ALOKA ARIETTA 850 | October 31, 2017 |
| K171738 | Supria True64 | August 18, 2017 |