Home / Device Classification / IWE

IWE — Monitor, Patient Position, Light-Beam Class I

FDA Device Classification

Classification Details

Product Code
IWE
Device Class
Class I
Regulation Number
892.5780
Submission Type
Review Panel
RA
Medical Specialty
Radiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K152303gammexCT Sim Laser SystemSeptember 11, 2015
K973162hogan and hartsonDUAL RADIATION TARGETING SYSTEM DRTS DRAPENovember 20, 1997
K955236medtecGREEN TEC-2100May 24, 1996
K954414diacorCENTRALITE BACKPOINTEROctober 23, 1995
K950293medtecTEC-2110 GREEN LASER MODEL MT-HNGAugust 18, 1995
K950112diacorCENTRALITE(R)-DLL SERIESAugust 16, 1995
K951601medtecMED-TEC STRING RETICLE TRAYMay 11, 1995
K943802medtecHP BACK POINTER SYSTEMDecember 7, 1994
K943381philips medical systems north americaLASER ALIGNMENT TOOLAugust 9, 1994
K941169medtecTEC 2101 (MODEL MT-HPLGD)July 18, 1994
K935760medtecTEC 2100 (MODEL MT-LPLGD)January 25, 1994
K934519medtecRADIATION EXIT VERIFICATION SYSTEM/BACK POINTER SYSTEMDecember 13, 1993
K931974a2jAZ 92October 8, 1993
K930294cp bio-medicalPATPOS GREENJune 4, 1993
K930296cp bio-medicalPATPOS REDMay 21, 1993
K930295cp bio-medicalPATPOS COMPACTMay 21, 1993
K923619medical alignment systemsACCULITE SSLNovember 16, 1992
K904127a2jA2J TELEMETERJanuary 4, 1991
K904753scanditronixDIOLASENovember 9, 1990
K893398diacorCENTRALITE BACKPOINTERAugust 17, 1989