CIRCLEXO.3T X-RAY TUBE ASSEMBLY
Device Facts
| Record ID | K920387 |
|---|---|
| Device Name | CIRCLEXO.3T X-RAY TUBE ASSEMBLY |
| Applicant | Shimadzu Medical Systems |
| Product Code | ITY · Radiology |
| Decision Date | Apr 14, 1992 |
| 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.
