GE Healthcare Japan Corporation
FDA Regulatory Profile
Summary
- Total Recalls
- 4
- 510(k) Clearances
- 9
- Inspections
- 3
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2873-2018 | Class II | GE Healthcare Optima CT660. The systems are intended for head, whole body, cardiac and vascular X-r | April 27, 2018 |
| Z-2871-2018 | Class II | GE Healthcare Optima CT660. Sold under the following product names: BEIJING OPTIMA CT660 PRO G | April 27, 2018 |
| Z-2870-2018 | Class II | GE Healthcare Revolution EVO, Optima CT660, Optima CT670, Optima CT680. The systems are intended fo | April 27, 2018 |
| Z-2872-2018 | Class II | GE Healthcare Optima CT540. The systems are intended for head, whole body, cardiac and vascular X-r | April 27, 2018 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K233698 | True Enhance DL | April 11, 2024 |
| K230807 | Deep Learning Image Reconstruction | April 20, 2023 |
| K220961 | Deep Learning Image Reconstruction | July 29, 2022 |
| K213938 | Revolution Ascend | February 4, 2022 |
| K212067 | Deep Learning Image Reconstruction | September 17, 2021 |
| K203169 | Revolution Ascend | November 20, 2020 |
| K193170 | Deep Learning Image Reconstruction | December 13, 2019 |
| K143345 | SIGNA Pioneer | July 10, 2015 |
| K103327 | DISCOVERY MR750W 3.0T | September 30, 2011 |