Xcision Medical Systems, LLC
FDA Regulatory Profile
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 2
- Inspections
- 1
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0750-2024 | Class II | GammaPod - Treatment Planning System-a component of the GammaPod Irradiation System. Ref: XMSGP030 | November 30, 2023 |
| Z-2081-2019 | Class II | GammaPod Stereotactic Radiotherapy System Model A, REF XMSGP030A00-0.02 Product Usage: GammaPod | July 3, 2019 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K180571 | GammaPod | April 4, 2018 |
| K172706 | GammaPod - Model A | December 22, 2017 |