IXI
- Product code
- IXI
- Device name
- Block, Beam-Shaping, Radiation Therapy
- Device class
- Class 2
- 21 CFR
- 21 CFR 892.5710
- Medical specialty
- Radiology
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 51
510(k) clearances, last 3 years (1)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K253025 | 2026-04-06 | Ricoh 3D For Healthcare, LLC | Ricoh 3D for Healthcare Bolus |
Official FDA classification page: IXI
Classification and pathway per current FDA publications. Data from openFDA (CC0).