ISORAD(TM) INTEGRAL BUILDUP PHOTON DIODES
Device Facts
| Record ID | K912250 |
|---|---|
| Device Name | ISORAD(TM) INTEGRAL BUILDUP PHOTON DIODES |
| Applicant | Theta Systems, Inc. |
| Product Code | IWB · Radiology |
| Decision Date | Nov 5, 1991 |
| 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.
