← Product Code [IXA](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXA) · K953444

# MCI OPTONIX ECONOMY CASSETTE (K953444)

_Mci Optonix, Inc. · IXA · Aug 2, 1995 · Radiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXA/K953444

## Device Facts

- **Applicant:** Mci Optonix, Inc.
- **Product Code:** [IXA](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXA.md)
- **Decision Date:** Aug 2, 1995
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 892.1850
- **Device Class:** Class 2
- **Review Panel:** Radiology

## Regulatory Identification

A radiographic film cassette is a device intended for use during diagnostic x-ray procedures to hold a radiographic film in close contact with an x-ray intensifying screen and to provide a light-proof enclosure for direct exposure of radiographic film.

## Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

---

**Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXA/K953444](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXA/K953444)

**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