Product Code: DXK FDA class 2 21 CFR 870.2330

Echocardiograph

Cardiovascular

The Echocardiograph is a cardiovascular imaging device that uses ultrasound waves to produce real-time images of the heart's structures and blood flow, enabling non-invasive assessment of cardiac anatomy, wall motion, valvular function, and hemodynamics. It is classified as an FDA Class 2 device, indicating moderate risk, and requires 510(k) premarket notification before marketing. The product code is DXK and it is regulated under 21 CFR 870.2330 within the Cardiovascular medical specialty. This device is eligible for third-party 510(k) review.

View on FDA

510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Basic Information

Product Code: DXK
Device Class: FDA class 2
Regulation Number: 870.2330
Medical Specialty: Cardiovascular
Review Panel: CV
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 78 510(k) clearances via K numbers.

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

FEI Numbers

This FDA classification entry is associated with 6 FEI numbers. Click on an entry to view related FDA registrations.

2124215: 406 registrations

3002095335: 124 registrations

3006382185: 3 registrations

3007695959: 89 registrations

3007738736: 132 registrations

3019130: 10 registrations