IXK · System, Imaging, X-Ray, Electrostatic
Radiology · 21 CFR 892.1630 · Class 2
Overview
| Product Code | IXK |
|---|---|
| Device Name | System, Imaging, X-Ray, Electrostatic |
| Regulation | 21 CFR 892.1630 |
| Device Class | Class 2 |
| Review Panel | Radiology |
| 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 | DIGITAL X-RAY DETECTORS FAMILY KRC AND DIRA | Electron Jsco. | Apr 29, 2011 | SESE |
| K072766 | PVMED DDR 2520 DIGITAL IMAGING SYSTEM | Portavision Medical | Dec 11, 2007 | SESE |
| K042779 | RADIOTHERAPY SOLUTION BASED ON CR | Agfa Corp. | Oct 21, 2004 | SESE |
| K032654 | PORT CASSETTE | Orex Computed Radiography, Ltd. | Oct 9, 2003 | SESE |
| K003689 | CANON X-RAY DIGITAL CAMERA, MODEL CXDI-31 | Canon USA, Inc. | Jan 2, 2002 | SESE |
| K000159 | AGFA DIAGNOSTIC CENTER ADC, ADC COMPACT, AND ADC SOLO | Agfa Corp. | Feb 16, 2000 | SESE |
| K942561 | FUJI FCR IMAGE PROCESSING UNIT IP-U515 | Fujifilm Medical System U.S.A., Inc. | Dec 23, 1994 | SESE |
| K934949 | DIGORA | Orion Corporation Soredex | Feb 10, 1994 | SESE |
| K931002 | FUJI COMPUTED RADIOGRAP HI-C654 DMS CRT IMAGE CONS | Fujifilm Medical System U.S.A., Inc. | Jun 8, 1993 | SESE |
| K924459 | DIGISCAN 2 | Siemens Medical Solutions USA, Inc. | Dec 17, 1992 | SESE |
| K923990 | FUJI COMPUTED RADIOGRAPHY HI-C652B DMS CRT IMAGE | Fujifilm Medical System U.S.A., Inc. | Dec 17, 1992 | SESE |
| K924012 | FUJI COMPUTED RADIOGRAPHY HI-C653 DMS CRT IMAGE | Fujifilm Medical System U.S.A., Inc. | Oct 16, 1992 | SESE |
| K853459 | XERORADIOGRAPHY LIQUID TONER IMAGING SYSTEM | Xerox Medical Systems | Oct 30, 1985 | SESE |
| K761022 | 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
