STEREOTACTIC 60 COBALT GAMMA SYSTEM--GAMMAKNIFE
Device Facts
| Record ID | K827583 |
|---|---|
| Device Name | STEREOTACTIC 60 COBALT GAMMA SYSTEM--GAMMAKNIFE |
| Applicant | Nucletronix, Inc. |
| Product Code | IWB · Radiology |
| Decision Date | Sep 29, 1982 |
| 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.
