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
78 devices
49–72 of 78
Cleared Sep 20, 1985
KONTRON SIGMA ISC ECHOCARDIOGRAPH SYSTEM
K852543
Kontron Instruments, Inc.
Cardiovascular · 98d
Cleared Jul 12, 1985
ACCUCOM CARDIAC OUTPUT MONITOR
K851426
Lawrence Medical Systems, Inc.
Cardiovascular · 93d
Cleared Jun 10, 1985
DEL MAR AVIONICS 8300 SECTOR IMAGER SYS
K844896
Del Mar Avionics
Cardiovascular · 175d
Cleared Jan 31, 1985
COLOR DOPPLER 880
K843643
Irex Corp.
Cardiovascular · 136d
Cleared Oct 19, 1984
CARDIOSCAN - TM BEING APPLIED FOR
K841263
Interspec, Inc.
Cardiovascular · 207d
Cleared Oct 04, 1982
M-MODE ANALYSIS SYSTEM
K822425
User Resources, Inc.
Cardiovascular · 53d
Cleared Aug 31, 1982
FRANKLIN QUANTIC 1200
K822236
Bruce Franklin, Inc.
Cardiovascular · 34d
Cleared Mar 02, 1982
ALLTEK BROMPTON ENCODER
K820145
Alltek Hospital Supplies , Ltd.
Cardiovascular · 42d
Cleared Mar 01, 1982
MAVIS C
K813002
Philips Medical Systems (Cleveland), Inc.
Radiology · 126d
Cleared Nov 16, 1981
ULTRA COM
K812209
Ultranamics, Inc.
Cardiovascular · 104d
Cleared Nov 16, 1981
SKI 5000
K812646
Smithkline Diagnostics, Inc.
Cardiovascular · 60d
Cleared Sep 09, 1981
ANGIOSCAN SPECTRUM ANALYZER
K812184
Unigon Industries, Inc.
Cardiovascular · 37d
Cleared Aug 12, 1981
SP-100-B SMALL PARTS SCANNER SYSTEM
K811595
Highstoy
Radiology · 65d
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 Dec 18, 1980
PFIZONIC 100 ULTRASOUND SCANNER
K802529
Pfizer Medical Systems, Inc.
Radiology · 63d
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
SINVISION LINEAR ARRAY REAL TIME
K800653
Kt Medical, Inc.
Cardiovascular · 119d
Cleared Jul 21, 1980
LINEAR ARRAY SCANNER
K800805
Philips Medical Systems (Cleveland), Inc.
Cardiovascular · 102d
Cleared Jul 21, 1980
HIGH STOY SMALL PARTS SCANNER #SP-100B
K800850
Highstoy
Cardiovascular · 97d
Cleared Jun 26, 1980
CAMBRIDGE CARDIAC DIAGNOSTIC SYSTEM
K801224
Cambridge Instruments, Inc.
Cardiovascular · 35d
Cleared Feb 13, 1980
IPCO M-101 ECHOCARDIOGRAPH (IPCO ULTRA-
K792373
Ipco Corp.
Cardiovascular · 79d