Browse hierarchy: [Radiology (RA)](/submissions/RA) → [Subpart B — Diagnostic Devices](/submissions/RA/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 892.1400](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/892.1400) → IXD — Source, Calibration, Sealed, Nuclear

# IXD · Source, Calibration, Sealed, Nuclear

_Radiology · 21 CFR 892.1400 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXD

## Overview

- **Product Code:** IXD
- **Device Name:** Source, Calibration, Sealed, Nuclear
- **Regulation:** [21 CFR 892.1400](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/892.1400)
- **Device Class:** 1
- **Review Panel:** [Radiology](/submissions/RA)

## 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](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXD/K850208.md) | FLOOD SOURCES & DOSE CALIBRATORS W/VARIOUS NUCLIDS | Syncor Intl. Corp. | Mar 26, 1985 | SESE |
| [K812235](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXD/K812235.md) | GOLD(AU 195) SPOT MARKER SOURCES | Amersham Corp. | Sep 9, 1981 | SESE |

## Top Applicants

- Syncor Intl. Corp. — 1 clearance
- Amersham Corp. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXD](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXD)

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