← Product Code [IZJ](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZJ) · K945580

# DSP OPTION (K945580)

_Philips Medical Systems (Cleveland), Inc. · IZJ · Jan 30, 1995 · Radiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZJ/K945580

## Device Facts

- **Applicant:** Philips Medical Systems (Cleveland), Inc.
- **Product Code:** [IZJ](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZJ.md)
- **Decision Date:** Jan 30, 1995
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 892.1620
- **Device Class:** Class 2
- **Review Panel:** Radiology

## Regulatory Identification

A cine or spot fluorographic x-ray camera is a device intended to photograph diagnostic images produced by x-rays with an image intensifier.

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**Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZJ/K945580](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZJ/K945580)

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