LEAD BLOCKS
Device Facts
| Record ID | K010172 |
|---|---|
| Device Name | LEAD BLOCKS |
| Applicant | Arplay Medical S.A. |
| Product Code | IXI · Radiology |
| Decision Date | Apr 18, 2001 |
| 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.