← Product Code [IZI](/productcode/IZI) · K926082

# CARDIAC STRESS TABLE, 056-180/UNIV ROLL STRESS ATT (K926082)

_Biodan Medical Systems, Ltd. · IZI · Dec 30, 1992 · Radiology · SESE_

**Canonical URL:** https://fda-staging.innolitics.com/device/K926082

## Device Facts

- **Applicant:** Biodan Medical Systems, Ltd.
- **Product Code:** [IZI](/productcode/IZI.md)
- **Decision Date:** Dec 30, 1992
- **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-staging.innolitics.com/device/K926082](https://fda-staging.innolitics.com/device/K926082)

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