IXF — Test-Pattern, Radiographic Class I

FDA Device Classification

FDA product code IXF covers "Test-Pattern, Radiographic", a Class I medical device regulated under 21 CFR 892.1940. Submissions are reviewed by the Radiology panel. At least 5 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
IXF
Device Class
Class I
Regulation Number
892.1940
Submission Type
Review Panel
RA
Medical Specialty
Radiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K865100computerized imaging reference systemsTISSUE-EQUIVALENT BREAST SIMULATORJanuary 12, 1987
K851812victoreenDIGITAL SUBTRACTION ANTIOGRAPHY PHANTOM 76-700/711June 5, 1985
K834481radiation measurementsDOPPLER PHANTOM FLOW CONTROL SYSJanuary 25, 1984
K834482radiation measurementsTISSUE MIMICKING ULTRASOUND PHANTOMSJanuary 25, 1984
K810254machlett laboratories1.5` FOCAL SPOT RESOLUTION PATTERNFebruary 19, 1981