FLOOD SOURCES & DOSE CALIBRATORS W/VARIOUS NUCLIDS
Device Facts
| Record ID | K850208 |
|---|---|
| Device Name | FLOOD SOURCES & DOSE CALIBRATORS W/VARIOUS NUCLIDS |
| Applicant | Syncor Intl. Corp. |
| Product Code | IXD · Radiology |
| Decision Date | Mar 26, 1985 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1400 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A nuclear sealed calibration source is a device that consists of an encapsulated reference radionuclide intended for calibration of medical nuclear radiation detectors.