DXK · Class II · 21 CFR 870.2330

FDA Product Code DXK: Echocardiograph

Leading manufacturers include Biosound, Inc., Prism Imaging, Inc. and Hitachi Medical Corp. of America.

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 28, 2003
IN-VISION IMAGING SYSTEM
K031148
Jomed, Inc.
Cardiovascular · 48d
Cleared Jan 14, 1994
9750 ATHENA ETHERNET OPTION
K934887
S & W Medico Teknik A/S
Cardiovascular · 94d
Cleared May 15, 1992
ACCESSORY TO GENESIS III (GCFM)
K913209
Biosound, Inc.
Radiology · 301d
Cleared Jun 25, 1991
CATHSCANNER(R) VISIONS(TM) 3.5F 54700/5.0F 54600
K911384
Endosonics Corp.
Cardiovascular · 89d
Cleared Apr 22, 1991
MODIFIED SYST: SONOS 500/1000 ULTRSOUND IMAG SYST
K904832
Hewlett-Packard Co.
Cardiovascular · 181d
Cleared Feb 25, 1991
VISTA VIEWING STATION
K904975
Prism Imaging, Inc.
Cardiovascular · 116d
Cleared Feb 25, 1991
CINE'VIEW - STRESS ECHO & IMAGE REVIEW
K904976
Prism Imaging, Inc.
Cardiovascular · 116d
Cleared Feb 25, 1991
CINE/VIEW PLUS - CARDIOLOGY WORKSTATION
K904977
Prism Imaging, Inc.
Cardiovascular · 116d
Cleared Feb 25, 1991
SOFTWARE PROGRAM USED W/PRISM PRODUCTS
K904978
Prism Imaging, Inc.
Cardiovascular · 116d
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 Nov 09, 1990
WASHINGTON CARDIAC MONITOR
K903710
Washington Biolab, Inc.
Cardiovascular · 87d
Cleared Oct 22, 1990
MODEL MD-5 DOPPLER
K901592
D. E. Hokanson, Inc.
Cardiovascular · 200d
Cleared Sep 19, 1990
TRANSESOPHAGEAL PROBE HOLDER & DISINFECTING COLUMN
K903414
Echo Ultrasound
Cardiovascular · 51d
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 17, 1990
LEOCOR CORFLO(TM) PUMP
K900350
Leocor, Inc.
Cardiovascular · 174d
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

About Product Code DXK - Regulatory Context