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DXK — Echocardiograph Class II

FDA Device Classification

Classification Details

Product Code
DXK
Device Class
Class II
Regulation Number
870.2330
Submission Type
Review Panel
CV
Medical Specialty
Cardiovascular
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K181042boston scientific corporationUltra ICE Plus – PI 9 MHz Peripheral Imaging CatheterMay 17, 2018
K160173boston scientific corporationUltra ICE Plus 9 MHz IntraCardiac Echo Catheter(eDFU), Ultra ICE Plus 9 MHz IntrFebruary 26, 2016
K031148jomedIN-VISION IMAGING SYSTEMMay 28, 2003
K934887s and w medico teknik9750 ATHENA ETHERNET OPTIONJanuary 14, 1994
K913209biosoundACCESSORY TO GENESIS III (GCFM)May 15, 1992
K911384endosonicsCATHSCANNER(R) VISIONS(TM) 3.5F 54700/5.0F 54600June 25, 1991
K904832hewlett-packardMODIFIED SYST: SONOS 500/1000 ULTRSOUND IMAG SYSTApril 22, 1991
K904978prism imagingSOFTWARE PROGRAM USED W/PRISM PRODUCTSFebruary 25, 1991
K904977prism imagingCINE/VIEW PLUS - CARDIOLOGY WORKSTATIONFebruary 25, 1991
K904975prism imagingVISTA VIEWING STATIONFebruary 25, 1991
K904976prism imagingCINE'VIEW - STRESS ECHO & IMAGE REVIEWFebruary 25, 1991
K910029spacelabsPATIENT CARE MANAGEMENT SYSTEM MODIFICATIONJanuary 31, 1991
K903839interspecINTERSPEC APOGEENovember 16, 1990
K903710washington biolabWASHINGTON CARDIAC MONITORNovember 9, 1990
K901592d. e. hokansonMODEL MD-5 DOPPLEROctober 22, 1990
K903414echo ultrasoundTRANSESOPHAGEAL PROBE HOLDER & DISINFECTING COLUMNSeptember 19, 1990
K901658hitachi medical corp. of americaADD'L TRANSDUCER FOR USE W/EUB-165 ULTRASOUNDSeptember 4, 1990
K901657hitachi medical corp. of americaADD'L TRANSDUCER FOR USE W/EUB-565 ULTRASOUNDSeptember 4, 1990
K900350leocorLEOCOR CORFLO(TM) PUMPJuly 17, 1990
K901562cardiovascular imaging systemsCVIS INSIGHT IMAGING CATHETERJuly 9, 1990