KPW — Device, Beam Limiting, X-Ray, Diagnostic Class II

FDA Device Classification

Classification Details

Product Code
KPW
Device Class
Class II
Regulation Number
892.1610
Submission Type
Review Panel
RA
Medical Specialty
Radiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K093596lumosLUMOS, MODEL R 72BJanuary 12, 2010
K062788umi internationalCOLLIMATOR, MODEL M-38December 28, 2006
K030487ralcoR 72August 1, 2003
K954310toshiba medical systemsBLA-800AOctober 18, 1995
K946320ralcoR 302May 11, 1995
K914184precise opticsP2020-8-0 BEAM-LIMITING DEVICENovember 27, 1991
K904587l. keroackDENSICOMP 250January 24, 1991
K904044toshiba america medical systems, in.cTF-63SANovember 29, 1990
K904489eureka x-ray tubeEUREKA EXTENSION CYLINDERSOctober 15, 1990
K820306tecnomedRALCO COLLIMATOR, AUTOMATIC RADIOGRAPHICMarch 5, 1982
K820305tecnomedRALCO COLLIMATORS, MANUAL RADIOGRAPHICMarch 4, 1982
K820119arrow x-rayPODIOSCOPE BY ARROWFebruary 18, 1982
K811450wedge filtration systemALUMINUM FILTRATION SYSTEMJuly 2, 1981
K791504dial-x instrumentsAUTOMATIC POSITIVE BEAM COLLIMATORSeptember 7, 1979
K781984siemensCOLLIMATOR, HEART CONTOURDecember 4, 1978
K770335litton medical systemsCOLLIMATOR, AUTOMATICFebruary 28, 1977