POLYDOROS SX 65 AND 80
Device Facts
| Record ID | K950883 |
|---|---|
| Device Name | POLYDOROS SX 65 AND 80 |
| Applicant | Siemens Medical Solutions USA, Inc. |
| Product Code | IZO · Radiology |
| Decision Date | Apr 3, 1995 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1700 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A diagnostic x-ray high voltage generator is a device that is intended to supply and control the electrical energy applied to a diagnostic x-ray tube for medical purposes. This generic type of device may include a converter that changes alternating current to direct current, filament transformers for the x-ray tube, high voltage switches, electrical protective devices, or other appropriate elements.
