AOS IMPLANT TUBES, IMPLANT NEEDLES & RETAINING BOTTONS
Device Facts
| Record ID | K062826 |
|---|---|
| Device Name | AOS IMPLANT TUBES, IMPLANT NEEDLES & RETAINING BOTTONS |
| Applicant | Alpha-Omega Services, Inc. |
| Product Code | JAQ · Radiology |
| Decision Date | May 22, 2007 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.5700 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A remote controlled radionuclide applicator system is an electromechanical or pneumatic device intended to enable an operator to apply, by remote control, a radionuclide source into the body or to the surface of the body for radiation therapy. This generic type of device may include patient and equipment supports, component parts, treatment planning computer programs, and accessories.
