DMLC IV-ERGO
Device Facts
| Record ID | K001163 |
|---|---|
| Device Name | DMLC IV-ERGO |
| Applicant | 3D Line USA, Inc. |
| Product Code | IXI · Radiology |
| Decision Date | Oct 23, 2000 |
| 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.