GammaPod
FDA 510(k) clearance K180571 · decided 2018-04-04
Clearance details
- K-number
- K180571
- Device name
- GammaPod
- Applicant
- Xcision Medical Systems, LLC
- Decision
- Substantially Equivalent
- Date received
- 2018-03-05
- Decision date
- 2018-04-04
- Days to decision
- 30 days
- Clearance type
- Special
- Product code
- IWB
- Device class
- 2
- Regulation number
- 892.5750
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Columbia, MD, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| GammaPod - Treatment Planning System-a component of the GammaPod Irradiation System. Ref: recall (Z-0750-2024) | Xcision Medical Systems, LLC | 2024-01-18 |