THE COBALT SCALPEL
Device Facts
| Record ID | K960892 |
|---|---|
| Device Name | THE COBALT SCALPEL |
| Applicant | Nova Therapeutic System |
| Product Code | IWB · Radiology |
| Decision Date | Jun 3, 1996 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.5750 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A radionuclide radiation therapy system is a device intended to permit an operator to administer gamma radiation therapy, with the radiation source located at a distance from the patient's body. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts (including beam-limiting devices), and accessories.
