← Product Code [IZH](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZH) · K881882

# SENOGRAPHE 600T AND 600TS SENIX HF (K881882)

_General Electric Co. · IZH · May 25, 1988 · Radiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZH/K881882

## Device Facts

- **Applicant:** General Electric Co.
- **Product Code:** [IZH](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZH.md)
- **Decision Date:** May 25, 1988
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 892.1710
- **Device Class:** Class 2
- **Review Panel:** Radiology

## Regulatory Identification

A mammographic x-ray system is a device intended to be used to produce radiographs of the breast. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

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**Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZH/K881882](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZH/K881882)

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