CARDIOSCINT (LEFT VENTRICULAR FUNCTION MONITOR)
Device Facts
| Record ID | K902460 |
|---|---|
| Device Name | CARDIOSCINT (LEFT VENTRICULAR FUNCTION MONITOR) |
| Applicant | Oakfield Instruments, Ltd. |
| Product Code | IZD · Radiology |
| Decision Date | Aug 28, 1990 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1320 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A nuclear uptake probe is a device intended to measure the amount of radionuclide taken up by a particular organ or body region. This generic type of device may include a single or multiple detector probe, signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
