IXK — System, Imaging, X-Ray, Electrostatic Class II
FDA product code IXK covers "System, Imaging, X-Ray, Electrostatic", a Class II medical device regulated under 21 CFR 892.1630. Submissions are reviewed by the Radiology panel. At least 14 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- IXK
- Device Class
- Class II
- Regulation Number
- 892.1630
- Submission Type
- Review Panel
- RA
- Medical Specialty
- Radiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K093640 | electron jsco | DIGITAL X-RAY DETECTORS FAMILY KRC AND DIRA | April 29, 2011 |
| K072766 | portavision medical | PVMED DDR 2520 DIGITAL IMAGING SYSTEM | December 11, 2007 |
| K042779 | agfa | RADIOTHERAPY SOLUTION BASED ON CR | October 21, 2004 |
| K032654 | orex computed radiography | PORT CASSETTE | October 9, 2003 |
| K003689 | canon usa | CANON X-RAY DIGITAL CAMERA, MODEL CXDI-31 | January 2, 2002 |
| K000159 | agfa | AGFA DIAGNOSTIC CENTER ADC, ADC COMPACT, AND ADC SOLO | February 16, 2000 |
| K942561 | fujifilm medical system u.s.a | FUJI FCR IMAGE PROCESSING UNIT IP-U515 | December 23, 1994 |
| K934949 | orion corporation soredex | DIGORA | February 10, 1994 |
| K931002 | fujifilm medical system u.s.a | FUJI COMPUTED RADIOGRAP HI-C654 DMS CRT IMAGE CONS | June 8, 1993 |
| K924459 | siemens medical solutions usa | DIGISCAN 2 | December 17, 1992 |
| K923990 | fujifilm medical system u.s.a | FUJI COMPUTED RADIOGRAPHY HI-C652B DMS CRT IMAGE | December 17, 1992 |
| K924012 | fujifilm medical system u.s.a | FUJI COMPUTED RADIOGRAPHY HI-C653 DMS CRT IMAGE | October 16, 1992 |
| K853459 | xerox medical systems | XERORADIOGRAPHY LIQUID TONER IMAGING SYSTEM | October 30, 1985 |
| K761022 | xeroradiography | XERORADIOGRAPHY 125 SYSTEM - MODIFIED | November 24, 1976 |