DXK · Class II · 21 CFR 870.2330

FDA Product Code DXK: Echocardiograph

Leading manufacturers include Biosound, Inc., Hewlett-Packard Co. and Honeywell, Inc..

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 Apr 02, 1990
DOPPLER OPTION FOR PLATINUM
K900002
Philips Medical Systems North America, Inc.
Cardiovascular · 90d
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 Apr 25, 1988
SSD-870 CARDIO VASCULAR PHASED ARRAY SECTOR SCANN.
K880217
Ge Medical Systems Information Technologies
Cardiovascular · 96d
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
Cleared Feb 02, 1987
EUB 151 ULTRASOUND SYSTEM/EUB 150 ULTRASOUND
K862859
Biosound, Inc.
Cardiovascular · 188d
Cleared Feb 02, 1987
ATL'S ULTRAMARK 6 ULTRASOUND SYSTEM
K864657
Advanced Technology Laboratories, Inc.
Cardiovascular · 66d
Cleared Jul 09, 1986
MODEL UST-SSD 880L1-5 TRANESOPHAGEAL PHASED ARRAY
K861710
Johnson & Johnson Professionals, Inc.
Cardiovascular · 65d
Cleared Mar 12, 1986
SONOLAYER S, SSH-60A/SDS-60A
K853115
Toshiba Medical Systems
Cardiovascular · 231d
Cleared Mar 10, 1986
SONOLINE SX ULTRASOUND SCANNER
K852739
Siemens Medical Solutions USA, Inc.
Cardiovascular · 256d
Cleared Feb 20, 1986
SONOLAYER S, SSH-65A
K854606
Toshiba Medical Systems
Cardiovascular · 94d
Cleared Oct 31, 1985
IRREGULAR CURVE TRACING REVISITION & DOPPLER
K853769
Hewlett-Packard Co.
Cardiovascular · 52d
Cleared Sep 20, 1985
KONTRON SIGMA ISC ECHOCARDIOGRAPH SYSTEM
K852543
Kontron Instruments, Inc.
Cardiovascular · 98d

About Product Code DXK - Regulatory Context