X-RAY MONOBLOCK, MONOBLOCK XRS-60-330
Device Facts
| Record ID | K000052 |
|---|---|
| Device Name | X-RAY MONOBLOCK, MONOBLOCK XRS-60-330 |
| Applicant | Dynarad Corp. |
| Product Code | ITY · Radiology |
| Decision Date | Feb 10, 2000 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1760 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A diagnostic x-ray tube housing assembly is an x-ray generating tube encased in a radiation-shielded housing that is intended for diagnostic purposes. This generic type of device may include high voltage and filament transformers or other appropriate components.
