← Product Code [IZH](/productcode/IZH) · K010116

# PLANMED SOPHIE, PLANMED SOPHIE CLASSIC (K010116)

_Planmed OY · IZH · Mar 15, 2001 · Radiology · SESE_

**Canonical URL:** https://fda-staging.innolitics.com/device/K010116

## Device Facts

- **Applicant:** Planmed OY
- **Product Code:** [IZH](/productcode/IZH.md)
- **Decision Date:** Mar 15, 2001
- **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/K010116](https://fda-staging.innolitics.com/device/K010116)

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