← Product Code [IXD](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXD) · K812235

# GOLD(AU 195) SPOT MARKER SOURCES (K812235)

_Amersham Corp. · IXD · Sep 9, 1981 · Radiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXD/K812235

## Device Facts

- **Applicant:** Amersham Corp.
- **Product Code:** [IXD](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXD.md)
- **Decision Date:** Sep 9, 1981
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 892.1400
- **Device Class:** Class 1
- **Review Panel:** Radiology

## Regulatory Identification

A nuclear sealed calibration source is a device that consists of an encapsulated reference radionuclide intended for calibration of medical nuclear radiation detectors.

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**Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXD/K812235](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXD/K812235)

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