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
78 devices
25–48 of 78
Cleared Jun 10, 1985
DEL MAR AVIONICS 8300 SECTOR IMAGER SYS
K844896
Del Mar Avionics
Cardiovascular · 175d
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 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 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