Browse hierarchy: [Radiology (RA)](/submissions/RA) → [Subpart B — Diagnostic Devices](/submissions/RA/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 892.1630](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/892.1630) → IXK — System, Imaging, X-Ray, Electrostatic

# IXK · System, Imaging, X-Ray, Electrostatic

_Radiology · 21 CFR 892.1630 · Class 2_

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

## Overview

- **Product Code:** IXK
- **Device Name:** System, Imaging, X-Ray, Electrostatic
- **Regulation:** [21 CFR 892.1630](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/892.1630)
- **Device Class:** 2
- **Review Panel:** [Radiology](/submissions/RA)
- **3rd-party reviewable:** yes

## 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.

## Classification Rationale

Class II.

## Recent Cleared Devices (14 of 14)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K093640](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXK/K093640.md) | DIGITAL X-RAY DETECTORS FAMILY KRC AND DIRA | Electron Jsco. | Apr 29, 2011 | SESE |
| [K072766](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXK/K072766.md) | PVMED DDR 2520 DIGITAL IMAGING SYSTEM | Portavision Medical | Dec 11, 2007 | SESE |
| [K042779](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXK/K042779.md) | RADIOTHERAPY SOLUTION BASED ON CR | Agfa Corp. | Oct 21, 2004 | SESE |
| [K032654](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXK/K032654.md) | PORT CASSETTE | Orex Computed Radiography, Ltd. | Oct 9, 2003 | SESE |
| [K003689](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXK/K003689.md) | CANON X-RAY DIGITAL CAMERA, MODEL CXDI-31 | Canon USA, Inc. | Jan 2, 2002 | SESE |
| [K000159](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXK/K000159.md) | AGFA DIAGNOSTIC CENTER ADC, ADC COMPACT, AND ADC SOLO | Agfa Corp. | Feb 16, 2000 | SESE |
| [K942561](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXK/K942561.md) | FUJI FCR IMAGE PROCESSING UNIT IP-U515 | Fujifilm Medical System U.S.A., Inc. | Dec 23, 1994 | SESE |
| [K934949](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXK/K934949.md) | DIGORA | Orion Corporation Soredex | Feb 10, 1994 | SESE |
| [K931002](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXK/K931002.md) | FUJI COMPUTED RADIOGRAP HI-C654 DMS CRT IMAGE CONS | Fujifilm Medical System U.S.A., Inc. | Jun 8, 1993 | SESE |
| [K924459](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXK/K924459.md) | DIGISCAN 2 | Siemens Medical Solutions USA, Inc. | Dec 17, 1992 | SESE |
| [K923990](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXK/K923990.md) | FUJI COMPUTED RADIOGRAPHY HI-C652B DMS CRT IMAGE | Fujifilm Medical System U.S.A., Inc. | Dec 17, 1992 | SESE |
| [K924012](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXK/K924012.md) | FUJI COMPUTED RADIOGRAPHY HI-C653 DMS CRT IMAGE | Fujifilm Medical System U.S.A., Inc. | Oct 16, 1992 | SESE |
| [K853459](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXK/K853459.md) | XERORADIOGRAPHY LIQUID TONER IMAGING SYSTEM | Xerox Medical Systems | Oct 30, 1985 | SESE |
| [K761022](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXK/K761022.md) | XERORADIOGRAPHY 125 SYSTEM - MODIFIED | Xeroradiography | Nov 24, 1976 | SESE |

## Top Applicants

- Fujifilm Medical System U.S.A., Inc. — 4 clearances
- Agfa Corp. — 2 clearances
- Xerox Medical Systems — 1 clearance
- Xeroradiography — 1 clearance
- Siemens Medical Solutions USA, Inc. — 1 clearance

---

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

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