← Product Code [IZH](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZH) · K901558

# GIOTTO MAMMOGRAPHY HF (K901558)

_Medical Device Marketing Network, Inc. · IZH · Jul 3, 1990 · Radiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZH/K901558

## Device Facts

- **Applicant:** Medical Device Marketing Network, Inc.
- **Product Code:** [IZH](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZH.md)
- **Decision Date:** Jul 3, 1990
- **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.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZH/K901558](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZH/K901558)

**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