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Echocardiograph

FDA product code DXK · 78 cleared devices

Class 2 Cardiovascular

Regulation: 21 CFR 870.2330
Review panel: CV
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1977-01-25 – 2018-05-17

DXK 2018-05-17

Ultra ICE Plus – PI 9 MHz Peripheral Imaging Catheter

Applicant Boston Scientific Corporation

K number K181042

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DXK 2016-02-26

Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter(eDFU), Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter (Paper DFU)

Applicant Boston Scientific Corporation

K number K160173

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DXK 2003-05-28

IN-VISION IMAGING SYSTEM

Applicant Jomed, Inc.

K number K031148

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DXK 1994-01-14

9750 ATHENA ETHERNET OPTION

Applicant S & W Medico Teknik A/S

K number K934887

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DXK 1992-05-15

ACCESSORY TO GENESIS III (GCFM)

Applicant Biosound, Inc.

K number K913209

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DXK 1991-06-25

CATHSCANNER(R) VISIONS(TM) 3.5F 54700/5.0F 54600

Applicant Endosonics Corp.

K number K911384

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DXK 1991-04-22

MODIFIED SYST: SONOS 500/1000 ULTRSOUND IMAG SYST

Applicant Hewlett-Packard Co.

K number K904832

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DXK 1991-02-25

SOFTWARE PROGRAM USED W/PRISM PRODUCTS

Applicant Prism Imaging, Inc.

K number K904978

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DXK 1991-02-25

CINE/VIEW PLUS - CARDIOLOGY WORKSTATION

Applicant Prism Imaging, Inc.

K number K904977

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DXK 1991-02-25

CINE'VIEW - STRESS ECHO & IMAGE REVIEW

Applicant Prism Imaging, Inc.

K number K904976

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DXK 1991-02-25

VISTA VIEWING STATION

Applicant Prism Imaging, Inc.

K number K904975

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DXK 1991-01-31

PATIENT CARE MANAGEMENT SYSTEM MODIFICATION

Applicant Spacelabs, Inc.

K number K910029

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DXK 1990-11-16

INTERSPEC APOGEE

Applicant Interspec, Inc.

K number K903839

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DXK 1990-11-09

WASHINGTON CARDIAC MONITOR

Applicant Washington Biolab, Inc.

K number K903710

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DXK 1990-10-22

MODEL MD-5 DOPPLER

Applicant D. E. Hokanson, Inc.

K number K901592

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DXK 1990-09-19

TRANSESOPHAGEAL PROBE HOLDER & DISINFECTING COLUMN

Applicant Echo Ultrasound

K number K903414

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DXK 1990-09-04

ADD'L TRANSDUCER FOR USE W/EUB-165 ULTRASOUND

Applicant Hitachi Medical Corp. of America

K number K901658

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DXK 1990-09-04

ADD'L TRANSDUCER FOR USE W/EUB-565 ULTRASOUND

Applicant Hitachi Medical Corp. of America

K number K901657

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DXK 1990-07-17

LEOCOR CORFLO(TM) PUMP

Applicant Leocor, Inc.

K number K900350

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DXK 1990-07-09

CVIS INSIGHT IMAGING CATHETER

Applicant Cardiovascular Imaging Systems, Inc.

K number K901562

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DXK 1990-04-02

DOPPLER OPTION FOR PLATINUM

Applicant Philips Medical Systems North America, Inc.

K number K900002

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DXK 1990-03-22

EUB-165

Applicant Hitachi Medical Corp. of America

K number K895326

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DXK 1990-02-15

ULTRAMARK 7 ULTRASOUND SYSTEM

Applicant Advanced Technology Laboratories, Inc.

K number K896543

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DXK 1990-01-29

GENESIS III, (MOD. 7003/7004)

Applicant Biosound, Inc.

K number K894370

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DXK 1989-10-19

MODEL SSH-140A ULTRASOUND IMAGING SYSTEM

Applicant Toshiba America Medical Systems, In.C

K number K894632

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DXK 1989-06-22

SONOMICROMETER, ULTRASONIC DIMENSION SYSTEM, CARD.

Applicant Sonotek Corp.

K number K885349

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DXK 1989-02-03

RESUBMITTED AI 5200 ULTRASOUND TRANSDUCER

Applicant Phoenix Imaging

K number K883845

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DXK 1988-12-12

CATHSCANNER INTRAVASCULAR ULTRASONIC IMAGING SYST.

Applicant Advanced Biosearch Assn.

K number K883888

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DXK 1988-04-25

SSD-870 CARDIO VASCULAR PHASED ARRAY SECTOR SCANN.

Applicant Ge Medical Systems Information Technologies

K number K880217

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DXK 1988-04-22

EUB-305 DIAGNOSTIC ULTRASOUND DEVICE

Applicant Hitachi Medical Corp. of America

K number K870878

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DXK 1988-03-02

RT5000 W/QUANTI. SPEC. DOPPLER, CW DOPP. MODIFICA.

Applicant General Electric Co.

K number K871555

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DXK 1988-02-18

SONOLINE CF

Applicant Siemens Medical Laboratories, Inc.

K number K875272

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DXK 1988-02-18

SERIES 77000 ULTRASOUND IMAGING SYSTEM

Applicant Hewlett-Packard Co.

K number K873762

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DXK 1988-02-18

GENESIS II, 2.5/5.0 MHZ S.E/5.0MHZ/3.5 16/19 MM AN

Applicant Biosound, Inc.

K number K873032

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DXK 1987-11-06

GENESIS II

Applicant Biosound, Inc.

K number K871697

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DXK 1987-09-04

MULTIPLE

Applicant Del Mar Avionics

K number K863387

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DXK 1987-07-24

SSD-650 LINEAR, CONVEX SECTOR, ULTRASOUND SCANNING

Applicant Ge Medical Systems Information Technologies

K number K871400

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DXK 1987-06-24

MODEL 600 VASCULAR DUPLEX IMAGER

Applicant Multigon Industries, Inc.

K number K863589

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DXK 1987-02-02

ATL'S ULTRAMARK 6 ULTRASOUND SYSTEM

Applicant Advanced Technology Laboratories, Inc.

K number K864657

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DXK 1987-02-02

EUB 151 ULTRASOUND SYSTEM/EUB 150 ULTRASOUND

Applicant Biosound, Inc.

K number K862859

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DXK 1986-12-22

KENZ-ECG 102

Applicant Compumed, Inc.

K number K863965

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DXK 1986-07-09

MODEL UST-SSD 880L1-5 TRANESOPHAGEAL PHASED ARRAY

Applicant Johnson & Johnson Professionals, Inc.

K number K861710

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DXK 1986-03-25

CFM-10 VINGMED COLOR FLOW MAPPING SYSTEM

Applicant Vingmed, Inc.

K number K855229

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DXK 1986-03-12

SONOLAYER S, SSH-60A/SDS-60A

Applicant Toshiba Medical Systems

K number K853115

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DXK 1986-03-10

SONOLINE SX ULTRASOUND SCANNER

Applicant Siemens Medical Solutions USA, Inc.

K number K852739

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DXK 1986-02-20

SONOLAYER S, SSH-65A

Applicant Toshiba Medical Systems

K number K854606

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DXK 1985-10-31

IRREGULAR CURVE TRACING REVISITION & DOPPLER

Applicant Hewlett-Packard Co.

K number K853769

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DXK 1985-10-23

750 SD ULTRASOUND SCANNER(MODIFICATION)

Applicant Ultrasonix, Inc.

K number K851901

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DXK 1985-09-20

KONTRON SIGMA ISC ECHOCARDIOGRAPH SYSTEM

Applicant Kontron Instruments, Inc.

K number K852543

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DXK 1985-07-12

ACCUCOM CARDIAC OUTPUT MONITOR

Applicant Lawrence Medical Systems, Inc.

K number K851426

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DXK 1985-06-10

DEL MAR AVIONICS 8300 SECTOR IMAGER SYS

Applicant Del Mar Avionics

K number K844896

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DXK 1985-01-31

COLOR DOPPLER 880

Applicant Irex Corp.

K number K843643

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DXK 1984-10-19

CARDIOSCAN - TM BEING APPLIED FOR

Applicant Interspec, Inc.

K number K841263

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DXK 1982-10-04

M-MODE ANALYSIS SYSTEM

Applicant User Resources, Inc.

K number K822425

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DXK 1982-08-31

FRANKLIN QUANTIC 1200

Applicant Bruce Franklin, Inc.

K number K822236

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DXK 1982-03-02

ALLTEK BROMPTON ENCODER

Applicant Alltek Hospital Supplies , Ltd.

K number K820145

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DXK 1982-03-01

MAVIS C

Applicant Philips Medical Systems (Cleveland), Inc.

K number K813002

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DXK 1981-11-16

SKI 5000

Applicant Smithkline Diagnostics, Inc.

K number K812646

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DXK 1981-11-16

ULTRA COM

Applicant Ultranamics, Inc.

K number K812209

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DXK 1981-09-09

ANGIOSCAN SPECTRUM ANALYZER

Applicant Unigon Industries, Inc.

K number K812184

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DXK 1981-08-12

SP-100-B SMALL PARTS SCANNER SYSTEM

Applicant Highstoy

K number K811595

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DXK 1981-07-10

DC-1 CARDIAC IMAGING MODULE

Applicant Diasonics, Inc.

K number K811556

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DXK 1981-01-16

MARK III ULTRASONIC SCANNING SYSTEM

Applicant Advanced Technology Laboratories, Inc.

K number K802917

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DXK 1980-12-18

PFIZONIC 100 ULTRASOUND SCANNER

Applicant Pfizer Medical Systems, Inc.

K number K802529

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DXK 1980-11-26

CONTIUOUS WAVE DOPPLER ULTRASOUND

Applicant American Edwards Laboratories

K number K802670

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DXK 1980-10-03

U.I. OCTOSON

Applicant Ausonics Pty , Ltd.

K number K802030

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DXK 1980-07-21

HIGH STOY SMALL PARTS SCANNER #SP-100B

Applicant Highstoy

K number K800850

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DXK 1980-07-21

LINEAR ARRAY SCANNER

Applicant Philips Medical Systems (Cleveland), Inc.

K number K800805

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DXK 1980-07-21

SINVISION LINEAR ARRAY REAL TIME

Applicant Kt Medical, Inc.

K number K800653

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DXK 1980-07-21

ULTRA IMAGER

Applicant Honeywell, Inc.

K number K800553

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DXK 1980-06-26

CAMBRIDGE CARDIAC DIAGNOSTIC SYSTEM

Applicant Cambridge Instruments, Inc.

K number K801224

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DXK 1980-02-13

IPCO M-101 ECHOCARDIOGRAPH (IPCO ULTRA-

Applicant Ipco Corp.

K number K792373

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DXK 1980-01-17

SONACOLOR 6000

Applicant Carolina Medical Electronics

K number K792540

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DXK 1978-03-22

CATHODE RAY TUBE DISPLAY MODEL 1340A

Applicant Hewlett-Packard Co.

K number K780332

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DXK 1977-08-16

HIGH-SPEED SECTOR SCANNING SSL-52H

Applicant Toshiba Medical Systems

K number K771292

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DXK 1977-05-09

ECHOCARDIOGRAPHY SYS., MODEL 3860

Applicant Honeywell, Inc.

K number K770756

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DXK 1977-05-09

ECHOCARDIOGRAPHY SYS., MODEL 3830

Applicant Honeywell, Inc.

K number K770755

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DXK 1977-01-25

PRIMUS INTER PARESECHOCARDIOGRAPHY SYS.

Applicant Rohe Scientific Corp.

K number K770073

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