FDA 510(k) Applications for Medical Device Product Code "DXK"
(Echocardiograph)

FDA 510(k) Number Applicant Device Name Decision Date
K883888 ADVANCED BIOSEARCH ASSN. CATHSCANNER INTRAVASCULAR ULTRASONIC IMAGING SYST. 12/12/1988
K864657 ADVANCED TECHNOLOGY LABORATORIES, INC. ATL'S ULTRAMARK 6 ULTRASOUND SYSTEM 02/02/1987
K802917 ADVANCED TECHNOLOGY LABORATORIES, INC. MARK III ULTRASONIC SCANNING SYSTEM 01/16/1981
K896543 ADVANCED TECHNOLOGY LABORATORIES, INC. ULTRAMARK 7 ULTRASOUND SYSTEM 02/15/1990
K820145 ALLTEK HOSPITAL SUPPLIES LTD. ALLTEK BROMPTON ENCODER 03/02/1982
K802670 AMERICAN EDWARDS LABORATORIES CONTIUOUS WAVE DOPPLER ULTRASOUND 11/26/1980
K802030 AUSONICS PTY LTD. U.I. OCTOSON 10/03/1980
K913209 BIOSOUND, INC. ACCESSORY TO GENESIS III (GCFM) 05/15/1992
K862859 BIOSOUND, INC. EUB 151 ULTRASOUND SYSTEM/EUB 150 ULTRASOUND 02/02/1987
K871697 BIOSOUND, INC. GENESIS II 11/06/1987
K873032 BIOSOUND, INC. GENESIS II, 2.5/5.0 MHZ S.E/5.0MHZ/3.5 16/19 MM AN 02/18/1988
K894370 BIOSOUND, INC. GENESIS III, (MOD. 7003/7004) 01/29/1990
K160173 Boston Scientific Corporation Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter(eDFU), Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter (Paper DFU) 02/26/2016
K181042 Boston Scientific Corporation Ultra ICE Plus û PI 9 MHz Peripheral Imaging Catheter 05/17/2018
K822236 BRUCE FRANKLIN, INC. FRANKLIN QUANTIC 1200 08/31/1982
K801224 CAMBRIDGE INSTRUMENTS, INC. CAMBRIDGE CARDIAC DIAGNOSTIC SYSTEM 06/26/1980
K901562 CARDIOVASCULAR IMAGING SYSTEMS, INC. CVIS INSIGHT IMAGING CATHETER 07/09/1990
K792540 CAROLINA MEDICAL ELECTRONICS SONACOLOR 6000 01/17/1980
K863965 COMPUMED, INC. KENZ-ECG 102 12/22/1986
K901592 D. E. HOKANSON, INC. MODEL MD-5 DOPPLER 10/22/1990
K844896 DEL MAR AVIONICS DEL MAR AVIONICS 8300 SECTOR IMAGER SYS 06/10/1985
K863387 DEL MAR AVIONICS MULTIPLE 09/04/1987
K811556 DIASONICS, INC. DC-1 CARDIAC IMAGING MODULE 07/10/1981
K903414 ECHO ULTRASOUND TRANSESOPHAGEAL PROBE HOLDER & DISINFECTING COLUMN 09/19/1990
K911384 ENDOSONICS CORP. CATHSCANNER(R) VISIONS(TM) 3.5F 54700/5.0F 54600 06/25/1991
K871400 GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES SSD-650 LINEAR, CONVEX SECTOR, ULTRASOUND SCANNING 07/24/1987
K880217 GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES SSD-870 CARDIO VASCULAR PHASED ARRAY SECTOR SCANN. 04/25/1988
K871555 GENERAL ELECTRIC CO. RT5000 W/QUANTI. SPEC. DOPPLER, CW DOPP. MODIFICA. 03/02/1988
K780332 HEWLETT-PACKARD CO. CATHODE RAY TUBE DISPLAY MODEL 1340A 03/22/1978
K853769 HEWLETT-PACKARD CO. IRREGULAR CURVE TRACING REVISITION & DOPPLER 10/31/1985
K904832 HEWLETT-PACKARD CO. MODIFIED SYST: SONOS 500/1000 ULTRSOUND IMAG SYST 04/22/1991
K873762 HEWLETT-PACKARD CO. SERIES 77000 ULTRASOUND IMAGING SYSTEM 02/18/1988
K800850 HIGHSTOY HIGH STOY SMALL PARTS SCANNER #SP-100B 07/21/1980
K811595 HIGHSTOY SP-100-B SMALL PARTS SCANNER SYSTEM 08/12/1981
K901658 HITACHI MEDICAL CORP. OF AMERICA ADD'L TRANSDUCER FOR USE W/EUB-165 ULTRASOUND 09/04/1990
K901657 HITACHI MEDICAL CORP. OF AMERICA ADD'L TRANSDUCER FOR USE W/EUB-565 ULTRASOUND 09/04/1990
K895326 HITACHI MEDICAL CORP. OF AMERICA EUB-165 03/22/1990
K870878 HITACHI MEDICAL CORP. OF AMERICA EUB-305 DIAGNOSTIC ULTRASOUND DEVICE 04/22/1988
K770755 HONEYWELL, INC. ECHOCARDIOGRAPHY SYS., MODEL 3830 05/09/1977
K770756 HONEYWELL, INC. ECHOCARDIOGRAPHY SYS., MODEL 3860 05/09/1977
K800553 HONEYWELL, INC. ULTRA IMAGER 07/21/1980
K841263 INTERSPEC, INC. CARDIOSCAN - TM BEING APPLIED FOR 10/19/1984
K903839 INTERSPEC, INC. INTERSPEC APOGEE 11/16/1990
K792373 IPCO CORP. IPCO M-101 ECHOCARDIOGRAPH (IPCO ULTRA- 02/13/1980
K843643 IREX CORP. COLOR DOPPLER 880 01/31/1985
K861710 JOHNSON & JOHNSON PROFESSIONALS, INC. MODEL UST-SSD 880L1-5 TRANESOPHAGEAL PHASED ARRAY 07/09/1986
K031148 JOMED, INC. IN-VISION IMAGING SYSTEM 05/28/2003
K852543 KONTRON INSTRUMENTS, INC. KONTRON SIGMA ISC ECHOCARDIOGRAPH SYSTEM 09/20/1985
K800653 KT MEDICAL, INC. SINVISION LINEAR ARRAY REAL TIME 07/21/1980
K851426 LAWRENCE MEDICAL SYSTEMS, INC. ACCUCOM CARDIAC OUTPUT MONITOR 07/12/1985
K900350 LEOCOR, INC. LEOCOR CORFLO(TM) PUMP 07/17/1990
K863589 MULTIGON INDUSTRIES, INC. MODEL 600 VASCULAR DUPLEX IMAGER 06/24/1987
K802529 PFIZER MEDICAL SYSTEMS, INC. PFIZONIC 100 ULTRASOUND SCANNER 12/18/1980
K900002 PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. DOPPLER OPTION FOR PLATINUM 04/02/1990
K800805 PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. LINEAR ARRAY SCANNER 07/21/1980
K813002 PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. MAVIS C 03/01/1982
K883845 PHOENIX IMAGING RESUBMITTED AI 5200 ULTRASOUND TRANSDUCER 02/03/1989
K904976 PRISM IMAGING, INC. CINE'VIEW - STRESS ECHO & IMAGE REVIEW 02/25/1991
K904977 PRISM IMAGING, INC. CINE/VIEW PLUS - CARDIOLOGY WORKSTATION 02/25/1991
K904978 PRISM IMAGING, INC. SOFTWARE PROGRAM USED W/PRISM PRODUCTS 02/25/1991
K904975 PRISM IMAGING, INC. VISTA VIEWING STATION 02/25/1991
K770073 ROHE SCIENTIFIC CORP. PRIMUS INTER PARESECHOCARDIOGRAPHY SYS. 01/25/1977
K934887 S & W MEDICO TEKNIK A/S 9750 ATHENA ETHERNET OPTION 01/14/1994
K875272 SIEMENS MEDICAL LABORATORIES, INC. SONOLINE CF 02/18/1988
K852739 SIEMENS MEDICAL SOLUTIONS USA, INC. "SONOLINE SX" ULTRASOUND SCANNER 03/10/1986
K812646 SMITH KLINE DIAGNOSTICS, INC. SKI 5000 11/16/1981
K885349 SONOTEK CORP. SONOMICROMETER, ULTRASONIC DIMENSION SYSTEM, CARD. 06/22/1989
K910029 SPACELABS, INC. PATIENT CARE MANAGEMENT SYSTEM MODIFICATION 01/31/1991
K894632 TOSHIBA AMERICA MEDICAL SYSTEMS, INC. MODEL SSH-140A ULTRASOUND IMAGING SYSTEM 10/19/1989
K771292 TOSHIBA MEDICAL SYSTEMS HIGH-SPEED SECTOR SCANNING SSL-52H 08/16/1977
K853115 TOSHIBA MEDICAL SYSTEMS SONOLAYER S, SSH-60A/SDS-60A 03/12/1986
K854606 TOSHIBA MEDICAL SYSTEMS SONOLAYER S, SSH-65A 02/20/1986
K812209 ULTRANAMICS, INC. ULTRA COM 11/16/1981
K851901 ULTRASONIX, INC. 750 SD ULTRASOUND SCANNER(MODIFICATION) 10/23/1985
K812184 UNIGON INDUSTRIES, INC. ANGIOSCAN SPECTRUM ANALYZER 09/09/1981
K822425 USER RESOURCES, INC. M-MODE ANALYSIS SYSTEM 10/04/1982
K855229 VINGMED, INC. CFM-10 VINGMED COLOR FLOW MAPPING SYSTEM 03/25/1986
K903710 WASHINGTON BIOLAB, INC. WASHINGTON CARDIAC MONITOR 11/09/1990


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