← Product Code [IZP](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZP) · K842903

# SEP PROGRAMMER FOR PUCK U & UD FILMCHANG (K842903)

_Elema-Schonander, Inc. · IZP · Aug 21, 1984 · Radiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZP/K842903

## Device Facts

- **Applicant:** Elema-Schonander, Inc.
- **Product Code:** [IZP](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZP.md)
- **Decision Date:** Aug 21, 1984
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 892.1870
- **Device Class:** Class 2
- **Review Panel:** Radiology

## Regulatory Identification

A radiographic film/cassette changer programmer is a device intended to be used to control the operations of a film or cassette changer during serial medical radiography.

## 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/IZP/K842903](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZP/K842903)

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