← Product Code [IZI](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZI) · K945293

# TOP ACOM STATION (K945293)

_Siemens Medical Solutions USA, Inc. · IZI · Jan 5, 1995 · Radiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZI/K945293

## Device Facts

- **Applicant:** Siemens Medical Solutions USA, Inc.
- **Product Code:** [IZI](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZI.md)
- **Decision Date:** Jan 5, 1995
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 892.1600
- **Device Class:** Class 2
- **Review Panel:** Radiology

## Regulatory Identification

An angiographic x-ray system is a device intended for radiologic visualization of the heart, blood vessels, or lymphatic system during or after injection of a contrast medium. 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/IZI/K945293](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZI/K945293)

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