Product code DXK— Cardiovascular

FDA has cleared 78 devices under product code DXK between 1977 and 2018, filed by 53 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 20181 clearance
• 20161 clearance
• 20031 clearance
• 19941 clearance
• 19921 clearance
• 19917 clearances
• 199012 clearances
• 19893 clearances
• 19887 clearances
• 19876 clearances
• 19866 clearances
• 19856 clearances
• 19841 clearance
• 19824 clearances
• 19816 clearances

• Biosound, Inc.5 clearances
• Prism Imaging, Inc.4 clearances
• Hitachi Medical Corp. of America4 clearances
• Hewlett-Packard Co.4 clearances
• Toshiba Medical Systems3 clearances
• Honeywell, Inc.3 clearances
• Advanced Technology Laboratories, Inc.3 clearances
• Philips Medical Systems (Cleveland), Inc.2 clearances
• Interspec, Inc.2 clearances
• Highstoy2 clearances

• K181042 — Ultra ICE Plus PI 9 MHz Peripheral Imaging CatheterBoston Scientific Corporation·2018-05-17
• K160173 — Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter(eDFU), Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter (Paper DFU)Boston Scientific Corporation·2016-02-26
• K031148 — IN-VISION IMAGING SYSTEMJomed, Inc.·2003-05-28
• K934887 — 9750 ATHENA ETHERNET OPTIONS & W Medico Teknik A/S·1994-01-14
• K913209 — ACCESSORY TO GENESIS III (GCFM)Biosound, Inc.·1992-05-15
• K911384 — CATHSCANNER(R) VISIONS(TM) 3.5F 54700/5.0F 54600Endosonics Corp.·1991-06-25
• K904832 — MODIFIED SYST: SONOS 500/1000 ULTRSOUND IMAG SYSTHewlett-Packard Co.·1991-04-22
• K904975 — VISTA VIEWING STATIONPrism Imaging, Inc.·1991-02-25
• K904976 — CINE'VIEW - STRESS ECHO & IMAGE REVIEWPrism Imaging, Inc.·1991-02-25
• K904977 — CINE/VIEW PLUS - CARDIOLOGY WORKSTATIONPrism Imaging, Inc.·1991-02-25
• K904978 — SOFTWARE PROGRAM USED W/PRISM PRODUCTSPrism Imaging, Inc.·1991-02-25
• K910029 — PATIENT CARE MANAGEMENT SYSTEM MODIFICATIONSpacelabs, Inc.·1991-01-31
• K903839 — INTERSPEC APOGEEInterspec, Inc.·1990-11-16
• K903710 — WASHINGTON CARDIAC MONITORWashington Biolab, Inc.·1990-11-09
• K901592 — MODEL MD-5 DOPPLERD. E. Hokanson, Inc.·1990-10-22
• K903414 — TRANSESOPHAGEAL PROBE HOLDER & DISINFECTING COLUMNEcho Ultrasound·1990-09-19
• K901657 — ADD'L TRANSDUCER FOR USE W/EUB-565 ULTRASOUNDHitachi Medical Corp. of America·1990-09-04
• K901658 — ADD'L TRANSDUCER FOR USE W/EUB-165 ULTRASOUNDHitachi Medical Corp. of America·1990-09-04
• K900350 — LEOCOR CORFLO(TM) PUMPLeocor, Inc.·1990-07-17
• K901562 — CVIS INSIGHT IMAGING CATHETERCardiovascular Imaging Systems, Inc.·1990-07-09
• K900002 — DOPPLER OPTION FOR PLATINUMPhilips Medical Systems North America, Inc.·1990-04-02
• K895326 — EUB-165Hitachi Medical Corp. of America·1990-03-22
• K896543 — ULTRAMARK 7 ULTRASOUND SYSTEMAdvanced Technology Laboratories, Inc.·1990-02-15
• K894370 — GENESIS III, (MOD. 7003/7004)Biosound, Inc.·1990-01-29
• K894632 — MODEL SSH-140A ULTRASOUND IMAGING SYSTEMToshiba America Medical Systems, In.C·1989-10-19
• K885349 — SONOMICROMETER, ULTRASONIC DIMENSION SYSTEM, CARD.Sonotek Corp.·1989-06-22
• K883845 — RESUBMITTED AI 5200 ULTRASOUND TRANSDUCERPhoenix Imaging·1989-02-03
• K883888 — CATHSCANNER INTRAVASCULAR ULTRASONIC IMAGING SYST.Advanced Biosearch Assn.·1988-12-12
• K880217 — SSD-870 CARDIO VASCULAR PHASED ARRAY SECTOR SCANN.Ge Medical Systems Information Technologies·1988-04-25
• K870878 — EUB-305 DIAGNOSTIC ULTRASOUND DEVICEHitachi Medical Corp. of America·1988-04-22
• K871555 — RT5000 W/QUANTI. SPEC. DOPPLER, CW DOPP. MODIFICA.General Electric Co.·1988-03-02
• K873032 — GENESIS II, 2.5/5.0 MHZ S.E/5.0MHZ/3.5 16/19 MM ANBiosound, Inc.·1988-02-18
• K873762 — SERIES 77000 ULTRASOUND IMAGING SYSTEMHewlett-Packard Co.·1988-02-18
• K875272 — SONOLINE CFSiemens Medical Laboratories, Inc.·1988-02-18
• K871697 — GENESIS IIBiosound, Inc.·1987-11-06
• K863387 — MULTIPLEDel Mar Avionics·1987-09-04
• K871400 — SSD-650 LINEAR, CONVEX SECTOR, ULTRASOUND SCANNINGGe Medical Systems Information Technologies·1987-07-24
• K863589 — MODEL 600 VASCULAR DUPLEX IMAGERMultigon Industries, Inc.·1987-06-24
• K862859 — EUB 151 ULTRASOUND SYSTEM/EUB 150 ULTRASOUNDBiosound, Inc.·1987-02-02
• K864657 — ATL'S ULTRAMARK 6 ULTRASOUND SYSTEMAdvanced Technology Laboratories, Inc.·1987-02-02
• K863965 — KENZ-ECG 102Compumed, Inc.·1986-12-22
• K861710 — MODEL UST-SSD 880L1-5 TRANESOPHAGEAL PHASED ARRAYJohnson & Johnson Professionals, Inc.·1986-07-09
• K855229 — CFM-10 VINGMED COLOR FLOW MAPPING SYSTEMVingmed, Inc.·1986-03-25
• K853115 — SONOLAYER S, SSH-60A/SDS-60AToshiba Medical Systems·1986-03-12
• K852739 — SONOLINE SX ULTRASOUND SCANNERSiemens Medical Solutions USA, Inc.·1986-03-10
• K854606 — SONOLAYER S, SSH-65AToshiba Medical Systems·1986-02-20
• K853769 — IRREGULAR CURVE TRACING REVISITION & DOPPLERHewlett-Packard Co.·1985-10-31
• K851901 — 750 SD ULTRASOUND SCANNER(MODIFICATION)Ultrasonix, Inc.·1985-10-23
• K852543 — KONTRON SIGMA ISC ECHOCARDIOGRAPH SYSTEMKontron Instruments, Inc.·1985-09-20
• K851426 — ACCUCOM CARDIAC OUTPUT MONITORLawrence Medical Systems, Inc.·1985-07-12
• K844896 — DEL MAR AVIONICS 8300 SECTOR IMAGER SYSDel Mar Avionics·1985-06-10
• K843643 — COLOR DOPPLER 880Irex Corp.·1985-01-31
• K841263 — CARDIOSCAN - TM BEING APPLIED FORInterspec, Inc.·1984-10-19
• K822425 — M-MODE ANALYSIS SYSTEMUser Resources, Inc.·1982-10-04
• K822236 — FRANKLIN QUANTIC 1200Bruce Franklin, Inc.·1982-08-31
• K820145 — ALLTEK BROMPTON ENCODERAlltek Hospital Supplies , Ltd.·1982-03-02
• K813002 — MAVIS CPhilips Medical Systems (Cleveland), Inc.·1982-03-01
• K812209 — ULTRA COMUltranamics, Inc.·1981-11-16
• K812646 — SKI 5000Smithkline Diagnostics, Inc.·1981-11-16
• K812184 — ANGIOSCAN SPECTRUM ANALYZERUnigon Industries, Inc.·1981-09-09
• K811595 — SP-100-B SMALL PARTS SCANNER SYSTEMHighstoy·1981-08-12
• K811556 — DC-1 CARDIAC IMAGING MODULEDiasonics, Inc.·1981-07-10
• K802917 — MARK III ULTRASONIC SCANNING SYSTEMAdvanced Technology Laboratories, Inc.·1981-01-16
• K802529 — PFIZONIC 100 ULTRASOUND SCANNERPfizer Medical Systems, Inc.·1980-12-18
• K802670 — CONTIUOUS WAVE DOPPLER ULTRASOUNDAmerican Edwards Laboratories·1980-11-26
• K802030 — U.I. OCTOSONAusonics Pty , Ltd.·1980-10-03
• K800553 — ULTRA IMAGERHoneywell, Inc.·1980-07-21
• K800653 — SINVISION LINEAR ARRAY REAL TIMEKt Medical, Inc.·1980-07-21
• K800805 — LINEAR ARRAY SCANNERPhilips Medical Systems (Cleveland), Inc.·1980-07-21
• K800850 — HIGH STOY SMALL PARTS SCANNER #SP-100BHighstoy·1980-07-21
• K801224 — CAMBRIDGE CARDIAC DIAGNOSTIC SYSTEMCambridge Instruments, Inc.·1980-06-26
• K792373 — IPCO M-101 ECHOCARDIOGRAPH (IPCO ULTRA-Ipco Corp.·1980-02-13
• K792540 — SONACOLOR 6000Carolina Medical Electronics·1980-01-17
• K780332 — CATHODE RAY TUBE DISPLAY MODEL 1340AHewlett-Packard Co.·1978-03-22
• K771292 — HIGH-SPEED SECTOR SCANNING SSL-52HToshiba Medical Systems·1977-08-16
• K770755 — ECHOCARDIOGRAPHY SYS., MODEL 3830Honeywell, Inc.·1977-05-09
• K770756 — ECHOCARDIOGRAPHY SYS., MODEL 3860Honeywell, Inc.·1977-05-09
• K770073 — PRIMUS INTER PARESECHOCARDIOGRAPHY SYS.Rohe Scientific Corp.·1977-01-25