← Product Code [IXA](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXA) · K953724

# CRONEX RADIATION THERAPY CASSETTE (K953724)

_E.I. Dupont DE Nemours & Co., Inc. · IXA · Sep 6, 1995 · Radiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXA/K953724

## Device Facts

- **Applicant:** E.I. Dupont DE Nemours & Co., Inc.
- **Product Code:** [IXA](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXA.md)
- **Decision Date:** Sep 6, 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.

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**Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXA/K953724](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXA/K953724)

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