DXK · Class II · 21 CFR 870.2330

FDA Product Code DXK: Echocardiograph

Leading manufacturers include Biosound, Inc., Hitachi Medical Corp. of America and Hewlett-Packard Co..

78
Total
78
Cleared
115d
Avg days
1977
Since

FDA 510(k) Cleared Echocardiograph Devices (Product Code DXK)

78 devices
1–24 of 78
Cleared May 17, 2018
Ultra ICE Plus – PI 9 MHz Peripheral Imaging Catheter
K181042
Boston Scientific Corporation
Cardiovascular · 28d
Cleared Feb 26, 2016
Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter(eDFU), Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter (Paper DFU)
K160173
Boston Scientific Corporation
Cardiovascular · 30d
Cleared May 15, 1992
ACCESSORY TO GENESIS III (GCFM)
K913209
Biosound, Inc.
Radiology · 301d
Cleared Apr 22, 1991
MODIFIED SYST: SONOS 500/1000 ULTRSOUND IMAG SYST
K904832
Hewlett-Packard Co.
Cardiovascular · 181d
Cleared Jan 31, 1991
PATIENT CARE MANAGEMENT SYSTEM MODIFICATION
K910029
Spacelabs, Inc.
Cardiovascular · 28d
Cleared Nov 16, 1990
INTERSPEC APOGEE
K903839
Interspec, Inc.
Cardiovascular · 87d
Cleared Oct 22, 1990
MODEL MD-5 DOPPLER
K901592
D. E. Hokanson, Inc.
Cardiovascular · 200d
Cleared Sep 04, 1990
ADD'L TRANSDUCER FOR USE W/EUB-565 ULTRASOUND
K901657
Hitachi Medical Corp. of America
Cardiovascular · 147d
Cleared Sep 04, 1990
ADD'L TRANSDUCER FOR USE W/EUB-165 ULTRASOUND
K901658
Hitachi Medical Corp. of America
Cardiovascular · 147d
Cleared Jul 09, 1990
CVIS INSIGHT IMAGING CATHETER
K901562
Cardiovascular Imaging Systems, Inc.
Cardiovascular · 97d
Cleared Apr 02, 1990
DOPPLER OPTION FOR PLATINUM
K900002
Philips Medical Systems North America, Inc.
Cardiovascular · 90d
Cleared Mar 22, 1990
EUB-165
K895326
Hitachi Medical Corp. of America
Cardiovascular · 205d
Cleared Feb 15, 1990
ULTRAMARK 7 ULTRASOUND SYSTEM
K896543
Advanced Technology Laboratories, Inc.
Cardiovascular · 90d
Cleared Jan 29, 1990
GENESIS III, (MOD. 7003/7004)
K894370
Biosound, Inc.
Cardiovascular · 199d
Cleared Oct 19, 1989
MODEL SSH-140A ULTRASOUND IMAGING SYSTEM
K894632
Toshiba America Medical Systems, In.C
Cardiovascular · 87d
Cleared Dec 12, 1988
CATHSCANNER INTRAVASCULAR ULTRASONIC IMAGING SYST.
K883888
Advanced Biosearch Assn.
Cardiovascular · 88d
Cleared Apr 25, 1988
SSD-870 CARDIO VASCULAR PHASED ARRAY SECTOR SCANN.
K880217
Ge Medical Systems Information Technologies
Cardiovascular · 96d
Cleared Apr 22, 1988
EUB-305 DIAGNOSTIC ULTRASOUND DEVICE
K870878
Hitachi Medical Corp. of America
Cardiovascular · 415d
Cleared Mar 02, 1988
RT5000 W/QUANTI. SPEC. DOPPLER, CW DOPP. MODIFICA.
K871555
General Electric Co.
Cardiovascular · 315d
Cleared Feb 18, 1988
GENESIS II, 2.5/5.0 MHZ S.E/5.0MHZ/3.5 16/19 MM AN
K873032
Biosound, Inc.
Cardiovascular · 198d
Cleared Feb 18, 1988
SERIES 77000 ULTRASOUND IMAGING SYSTEM
K873762
Hewlett-Packard Co.
Cardiovascular · 155d
Cleared Nov 06, 1987
GENESIS II
K871697
Biosound, Inc.
Cardiovascular · 190d
Cleared Sep 04, 1987
MULTIPLE
K863387
Del Mar Avionics
Cardiovascular · 366d
Cleared Jul 24, 1987
SSD-650 LINEAR, CONVEX SECTOR, ULTRASOUND SCANNING
K871400
Ge Medical Systems Information Technologies
Cardiovascular · 107d

About Product Code DXK - Regulatory Context