← Product Code [IXK](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXK) · K093640

# DIGITAL X-RAY DETECTORS FAMILY KRC AND DIRA (K093640)

_Electron Jsco. · IXK · Apr 29, 2011 · Radiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXK/K093640

## Device Facts

- **Applicant:** Electron Jsco.
- **Product Code:** [IXK](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXK.md)
- **Decision Date:** Apr 29, 2011
- **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/K093640](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXK/K093640)

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