ER-1000 CATHERIZATION C-ARM SYSTEMS
Device Facts
| Record ID | K914348 |
|---|---|
| Device Name | ER-1000 CATHERIZATION C-ARM SYSTEMS |
| Applicant | Shimadzu Medical Systems |
| Product Code | IYB · Radiology |
| Decision Date | Nov 1, 1991 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1770 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A diagnostic x-ray tube mount is a device intended to support and to position the diagnostic x-ray tube housing assembly for a medical radiographic procedure.