System, Imaging, X-Ray, Electrostatic
An electrostatic X-ray imaging system is a radiographic imaging device that uses electrostatic principles rather than traditional silver halide film chemistry to capture and record diagnostic X-ray images, providing an alternative imaging medium. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket notification. The product code is IXK, regulated under 21 CFR 892.1630, within the Radiology medical specialty. This device is eligible for third party 510(k) review.
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Basic Information
- Product Code
- IXK
- Device Class
- FDA class 2
- Regulation Number
- 892.1630
- Medical Specialty
- Radiology
- Review Panel
- RA
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 14 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K093640 | DIGITAL X-RAY DETECTORS FAMILY KRC AND DIRA | Apr 29, 2011 | Substantially Equivalent | Electron Jsco. |
| K072766 | PVMED DDR 2520 DIGITAL IMAGING SYSTEM | Dec 11, 2007 | Substantially Equivalent | Portavision Medical |
| K042779 | RADIOTHERAPY SOLUTION BASED ON CR | Oct 21, 2004 | Substantially Equivalent | Agfa Corp. |
| K032654 | PORT CASSETTE | Oct 09, 2003 | Substantially Equivalent | Orex Computed Radiography, Ltd. |
| K003689 | CANON X-RAY DIGITAL CAMERA, MODEL CXDI-31 | Jan 02, 2002 | Substantially Equivalent | Canon USA, Inc. |
| K000159 | AGFA DIAGNOSTIC CENTER ADC, ADC COMPACT, AND ADC SOLO | Feb 16, 2000 | Substantially Equivalent | Agfa Corp. |
| K942561 | FUJI FCR IMAGE PROCESSING UNIT IP-U515 | Dec 23, 1994 | Substantially Equivalent | Fujifilm Medical System U.S.A., Inc. |
| K934949 | DIGORA | Feb 10, 1994 | Substantially Equivalent | Orion Corporation Soredex |
| K931002 | FUJI COMPUTED RADIOGRAP HI-C654 DMS CRT IMAGE CONS | Jun 08, 1993 | Substantially Equivalent | Fujifilm Medical System U.S.A., Inc. |
| K924459 | DIGISCAN 2 | Dec 17, 1992 | Substantially Equivalent | Siemens Medical Solutions USA, Inc. |
| K923990 | FUJI COMPUTED RADIOGRAPHY HI-C652B DMS CRT IMAGE | Dec 17, 1992 | Substantially Equivalent | Fujifilm Medical System U.S.A., Inc. |
| K924012 | FUJI COMPUTED RADIOGRAPHY HI-C653 DMS CRT IMAGE | Oct 16, 1992 | Substantially Equivalent | Fujifilm Medical System U.S.A., Inc. |
| K853459 | XERORADIOGRAPHY LIQUID TONER IMAGING SYSTEM | Oct 30, 1985 | Substantially Equivalent | Xerox Medical Systems |
| K761022 | XERORADIOGRAPHY 125 SYSTEM - MODIFIED | Nov 24, 1976 | Substantially Equivalent | Xeroradiography |