← Product Code [IXK](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXK) · K924012

# FUJI COMPUTED RADIOGRAPHY HI-C653 DMS CRT IMAGE (K924012)

_Fujifilm Medical System U.S.A., Inc. · IXK · Oct 16, 1992 · Radiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXK/K924012

## Device Facts

- **Applicant:** Fujifilm Medical System U.S.A., Inc.
- **Product Code:** [IXK](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXK.md)
- **Decision Date:** Oct 16, 1992
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 892.1630
- **Device Class:** Class 2
- **Review Panel:** Radiology

## Regulatory Identification

An electrostatic x-ray imaging system is a device intended for medical purposes that uses an electrostatic field across a semiconductive plate, a gas-filled chamber, or other similar device to convert a pattern of x-radiation into an electrostatic image and, subsequently, into a visible image. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

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**Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXK/K924012](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXK/K924012)

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