← Product Code [IZI](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZI) · K903372

# CATH MULTIDIRECT BI-PLANE RADIO SYST MH-51A/MH-31A (K903372)

_Shimadzu Medical Systems · IZI · Nov 29, 1990 · Radiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZI/K903372

## Device Facts

- **Applicant:** Shimadzu Medical Systems
- **Product Code:** [IZI](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZI.md)
- **Decision Date:** Nov 29, 1990
- **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/K903372](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZI/K903372)

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