Philips Medical Systems Technologies Ltd.
FDA Regulatory Profile
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 4
- Inspections
- 1
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0497-2025 | Class II | Vue PACS Diagnostic Viewer with Vue PACS client 12.1.5 to 12.2.8.454 software Model Number: 114941 | October 10, 2024 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K244008 | Spectral CT | May 16, 2025 |
| K240844 | Spectral CT 7500 RT | October 18, 2024 |
| K240822 | Image Management V15 | April 24, 2024 |
| K173588 | Illumeo System | January 12, 2018 |