← Product Code [JWM](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/JWM) · K801917

# STAR (K801917)

_General Electric Co. · JWM · Sep 16, 1980 · Radiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/JWM/K801917

## Device Facts

- **Applicant:** General Electric Co.
- **Product Code:** [JWM](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/JWM.md)
- **Decision Date:** Sep 16, 1980
- **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/K801917](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/JWM/K801917)

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