IMAGER, BODY SECTION, RADIONUCLIDE
Device Facts
| Record ID | K780395 |
|---|---|
| Device Name | IMAGER, BODY SECTION, RADIONUCLIDE |
| Applicant | Union Carbide Corp. |
| Product Code | IYW · Radiology |
| Decision Date | Mar 31, 1978 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1300 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A nuclear rectilinear scanner is a device intended to image the distribution of radionuclides in the body by means of a detector (or detectors) whose position moves in two directions with respect to the patient. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.
