← Product Code [IZH](/productcode/IZH) · K884345

# MODEL ESP-200 MAMMOGRAPHIC SYSTEM (K884345)

_Acoma Medical Imaging, Inc. · IZH · Mar 23, 1989 · Radiology · SESE_

**Canonical URL:** https://fda-staging.innolitics.com/device/K884345

## Device Facts

- **Applicant:** Acoma Medical Imaging, Inc.
- **Product Code:** [IZH](/productcode/IZH.md)
- **Decision Date:** Mar 23, 1989
- **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-staging.innolitics.com/device/K884345](https://fda-staging.innolitics.com/device/K884345)

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