← Product Code [IZH](/productcode/IZH) · K873618

# STEREOTIX (K873618)

_Thomson-Cgr Medical Corp. · IZH · Nov 16, 1987 · Radiology · SESE_

**Canonical URL:** https://fda-staging.innolitics.com/device/K873618

## Device Facts

- **Applicant:** Thomson-Cgr Medical Corp.
- **Product Code:** [IZH](/productcode/IZH.md)
- **Decision Date:** Nov 16, 1987
- **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.

---

**Source:** [https://fda-staging.innolitics.com/device/K873618](https://fda-staging.innolitics.com/device/K873618)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com
