IZO — Generator, High-Voltage, X-Ray, Diagnostic Class I

FDA Device Classification

Classification Details

Product Code
IZO
Device Class
Class I
Regulation Number
892.1700
Submission Type
Review Panel
RA
Medical Specialty
Radiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K954666ge medical systemsMPH50, MPH65, AND MPH80November 24, 1995
K953582varian canadaHFX350, 30KW, 300MA, 1 OR 3 PHASE RADIOGRAPHIC & FLUOROSCOPIC X-RAY GENERATORSeptember 26, 1995
K953831nucletron-oldelftN 800 HFSeptember 8, 1995
K952822shimadzuSHIMADZU X-RAY HIGH VILTAGE GENERATOR AHD150GJuly 12, 1995
K952265control-xMILESTONW 350/450/550HF, PCX N350/450/550HF, TOP-X 350/450/550HF RADIOGRAPHIC X-July 6, 1995
K950883siemens medical solutions usaPOLYDOROS SX 65 AND 80April 3, 1995
K950694electromed intlCOMPACT-XMarch 31, 1995
K950291fischer imagingDIGITAL 625HFMarch 23, 1995
K950041scott imaging intlSII 360 APRMarch 21, 1995
K945453shimadzu medical systemsUD 150L-R IIMarch 21, 1995
K950040scott imaging intlSII 525 APRMarch 21, 1995
K945452shimadzu medical systemsUD 150L-FMarch 21, 1995
K945731bennett x-rayHFQ HIGH FREQUENCY RADIOGRAPHIC AND FLUROSCOPIC GENERATORSFebruary 15, 1995
K950037oldelft corp. of americaN 800 HFFebruary 15, 1995
K945668toshiba america medical systems, in.cKXO-80GDecember 27, 1994
K942731shimadzuSHIMAZU WHOLE BODY X-RAY CT SCANNER SCT-4800TF/GROctober 13, 1994
K944148fischer imagingMICRO X-30HFSeptember 16, 1994
K944150fischer imagingMICRO X-65 HFSeptember 16, 1994
K944147fischer imagingMICRO X-50 HFSeptember 16, 1994
K944149fischer imagingMICRO X-80 HFSeptember 16, 1994