← Product Code [KPX](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KPX) · K862575

# UNIVERSAL STAND FOR FILM CHANGER (K862575)

_Canon USA, Inc. · KPX · Jul 14, 1986 · Radiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KPX/K862575

## Device Facts

- **Applicant:** Canon USA, Inc.
- **Product Code:** [KPX](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KPX.md)
- **Decision Date:** Jul 14, 1986
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 892.1860
- **Device Class:** Class 2
- **Review Panel:** Radiology

## Regulatory Identification

A radiographic film/cassette changer is a device intended to be used during a radiologic procedure to move a radiographic film or cassette between x-ray exposures and to position it during the exposure.

## 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/KPX/K862575](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KPX/K862575)

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