← Product Code [IZH](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZH) · K955411

# DELTA 16 (K955411)

_Instrumentarium Imaging, Inc. · IZH · Mar 21, 1996 · Radiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZH/K955411

## Device Facts

- **Applicant:** Instrumentarium Imaging, Inc.
- **Product Code:** [IZH](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZH.md)
- **Decision Date:** Mar 21, 1996
- **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/K955411](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZH/K955411)

**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