CATH MULTIDIRECT BI-PLANE RADIO SYST MH-51A/MH-31A
Device Facts
| Record ID | K903372 |
|---|---|
| Device Name | CATH MULTIDIRECT BI-PLANE RADIO SYST MH-51A/MH-31A |
| Applicant | Shimadzu Medical Systems |
| Product Code | IZI · Radiology |
| Decision Date | Nov 29, 1990 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1600 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An angiographic x-ray system is a device intended for radiologic visualization of the heart, blood vessels, or lymphatic system during or after injection of a contrast medium. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
