← Product Code [IZH](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZH) · K003945

# OPDIMA (K003945)

_Siemens Medical Solutions USA, Inc. · IZH · Feb 2, 2001 · Radiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZH/K003945

## Device Facts

- **Applicant:** Siemens Medical Solutions USA, Inc.
- **Product Code:** [IZH](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZH.md)
- **Decision Date:** Feb 2, 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.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZH/K003945](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZH/K003945)

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