← Product Code [IZH](/productcode/IZH) · K001171

# DELTA 16 TACT (K001171)

_Instrumentarium Imaging, Inc. · IZH · May 12, 2000 · Radiology · SESE_

**Canonical URL:** https://fda.innolitics.com/device/K001171

## Device Facts

- **Applicant:** Instrumentarium Imaging, Inc.
- **Product Code:** [IZH](/productcode/IZH.md)
- **Decision Date:** May 12, 2000
- **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/device/K001171](https://fda.innolitics.com/device/K001171)

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