Ricoh 3D for Healthcare Bolus
Device Facts
| Record ID | K253025 |
|---|---|
| Device Name | Ricoh 3D for Healthcare Bolus |
| Applicant | Ricoh 3D For Healthcare, LLC |
| Product Code | IXI · Radiology |
| Decision Date | Apr 6, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.5710 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A radiation therapy beam-shaping block is a device made of a highly attenuating material (such as lead) intended for medical purposes to modify the shape of a beam from a radiation therapy source.
