MENTOR ISOLOADER AUTOMATIC NEEDLE LOADING SYSTEM AND PHYSICS WORKSTATION FOR BRACHYTHERAPY
Device Facts
| Record ID | K011493 |
|---|---|
| Device Name | MENTOR ISOLOADER AUTOMATIC NEEDLE LOADING SYSTEM AND PHYSICS WORKSTATION FOR BRACHYTHERAPY |
| Applicant | Mentor Corp. |
| Product Code | KPT · Radiology |
| Decision Date | Oct 1, 2002 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1360 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A radionuclide dose calibrator is a radiation detection device intended to assay radionuclides before their administration to patients.