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
78 devices
25–48 of 78
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
Cleared Jun 10, 1985
DEL MAR AVIONICS 8300 SECTOR IMAGER SYS
K844896
Del Mar Avionics
Cardiovascular · 175d
Cleared Oct 19, 1984
CARDIOSCAN - TM BEING APPLIED FOR
K841263
Interspec, Inc.
Cardiovascular · 207d
Cleared Mar 01, 1982
MAVIS C
K813002
Philips Medical Systems (Cleveland), Inc.
Radiology · 126d
Cleared Nov 16, 1981
SKI 5000
K812646
Smithkline Diagnostics, Inc.
Cardiovascular · 60d
Cleared Jul 10, 1981
DC-1 CARDIAC IMAGING MODULE
K811556
Diasonics, Inc.
Cardiovascular · 38d
Cleared Jan 16, 1981
MARK III ULTRASONIC SCANNING SYSTEM
K802917
Advanced Technology Laboratories, Inc.
Cardiovascular · 58d
Cleared Nov 26, 1980
CONTIUOUS WAVE DOPPLER ULTRASOUND
K802670
American Edwards Laboratories
Cardiovascular · 30d
Cleared Oct 03, 1980
U.I. OCTOSON
K802030
Ausonics Pty , Ltd.
Cardiovascular · 43d
Cleared Jul 21, 1980
ULTRA IMAGER
K800553
Honeywell, Inc.
Cardiovascular · 132d
Cleared Jul 21, 1980
LINEAR ARRAY SCANNER
K800805
Philips Medical Systems (Cleveland), Inc.
Cardiovascular · 102d
Cleared Feb 13, 1980
IPCO M-101 ECHOCARDIOGRAPH (IPCO ULTRA-
K792373
Ipco Corp.
Cardiovascular · 79d
Cleared Mar 22, 1978
CATHODE RAY TUBE DISPLAY MODEL 1340A
K780332
Hewlett-Packard Co.
Radiology · 22d
Cleared Aug 16, 1977
HIGH-SPEED SECTOR SCANNING SSL-52H
K771292
Toshiba Medical Systems
Cardiovascular · 68d
Cleared May 09, 1977
ECHOCARDIOGRAPHY SYS., MODEL 3830
K770755
Honeywell, Inc.
Cardiovascular · 14d
Cleared May 09, 1977
ECHOCARDIOGRAPHY SYS., MODEL 3860
K770756
Honeywell, Inc.
Cardiovascular · 14d