IXD · Source, Calibration, Sealed, Nuclear
Radiology · 21 CFR 892.1400 · Class 1
Overview
| Product Code | IXD |
|---|---|
| Device Name | Source, Calibration, Sealed, Nuclear |
| Regulation | 21 CFR 892.1400 |
| Device Class | Class 1 |
| Review Panel | Radiology |
Identification
A nuclear sealed calibration source is a device that consists of an encapsulated reference radionuclide intended for calibration of medical nuclear radiation detectors.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 892.9.
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K850208 | FLOOD SOURCES & DOSE CALIBRATORS W/VARIOUS NUCLIDS | Syncor Intl. Corp. | Mar 26, 1985 | SESE |
| K812235 | GOLD(AU 195) SPOT MARKER SOURCES | Amersham Corp. | Sep 9, 1981 | SESE |
Top Applicants
- Amersham Corp. — 1 clearance
- Syncor Intl. Corp. — 1 clearance
