IXK — System, Imaging, X-Ray, Electrostatic Class II

FDA Device Classification

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-NumberApplicantDevice NameDate
K093640electron jscoDIGITAL X-RAY DETECTORS FAMILY KRC AND DIRAApril 29, 2011
K072766portavision medicalPVMED DDR 2520 DIGITAL IMAGING SYSTEMDecember 11, 2007
K042779agfaRADIOTHERAPY SOLUTION BASED ON CROctober 21, 2004
K032654orex computed radiographyPORT CASSETTEOctober 9, 2003
K003689canon usaCANON X-RAY DIGITAL CAMERA, MODEL CXDI-31January 2, 2002
K000159agfaAGFA DIAGNOSTIC CENTER ADC, ADC COMPACT, AND ADC SOLOFebruary 16, 2000
K942561fujifilm medical system u.s.aFUJI FCR IMAGE PROCESSING UNIT IP-U515December 23, 1994
K934949orion corporation soredexDIGORAFebruary 10, 1994
K931002fujifilm medical system u.s.aFUJI COMPUTED RADIOGRAP HI-C654 DMS CRT IMAGE CONSJune 8, 1993
K924459siemens medical solutions usaDIGISCAN 2December 17, 1992
K923990fujifilm medical system u.s.aFUJI COMPUTED RADIOGRAPHY HI-C652B DMS CRT IMAGEDecember 17, 1992
K924012fujifilm medical system u.s.aFUJI COMPUTED RADIOGRAPHY HI-C653 DMS CRT IMAGEOctober 16, 1992
K853459xerox medical systemsXERORADIOGRAPHY LIQUID TONER IMAGING SYSTEMOctober 30, 1985
K761022xeroradiographyXERORADIOGRAPHY 125 SYSTEM - MODIFIEDNovember 24, 1976