← Product Code [JWM](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/JWM) · K812966

# 400T ECT SOFTWARE (K812966)

_General Electric Co. · JWM · Nov 24, 1981 · Radiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/JWM/K812966

## Device Facts

- **Applicant:** General Electric Co.
- **Product Code:** [JWM](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/JWM.md)
- **Decision Date:** Nov 24, 1981
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 892.1310
- **Device Class:** Class 2
- **Review Panel:** Radiology

## Regulatory Identification

A nuclear tomography system is a device intended to detect nuclear radiation in the body and produce images of a specific cross-sectional plane of the body by blurring or eliminating detail from other planes. This generic type of devices may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.

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**Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/JWM/K812966](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/JWM/K812966)

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