← Product Code [IZH](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZH) · K904953

# PLANMED SOPHIE (K904953)

_Planmeca USA, Inc. · IZH · Apr 18, 1991 · Radiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZH/K904953

## Device Facts

- **Applicant:** Planmeca USA, Inc.
- **Product Code:** [IZH](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZH.md)
- **Decision Date:** Apr 18, 1991
- **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/K904953](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZH/K904953)

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