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
25–48 of 78
Cleared Oct 19, 1989
MODEL SSH-140A ULTRASOUND IMAGING SYSTEM
K894632
Toshiba America Medical Systems, In.C
Cardiovascular · 87d
Cleared Jun 22, 1989
SONOMICROMETER, ULTRASONIC DIMENSION SYSTEM, CARD.
K885349
Sonotek Corp.
Cardiovascular · 176d
Cleared Feb 03, 1989
RESUBMITTED AI 5200 ULTRASOUND TRANSDUCER
K883845
Phoenix Imaging
Cardiovascular · 144d
Cleared Dec 12, 1988
CATHSCANNER INTRAVASCULAR ULTRASONIC IMAGING SYST.
K883888
Advanced Biosearch Assn.
Cardiovascular · 88d
Cleared Apr 25, 1988
SSD-870 CARDIO VASCULAR PHASED ARRAY SECTOR SCANN.
K880217
Ge Medical Systems Information Technologies
Cardiovascular · 96d
Cleared Apr 22, 1988
EUB-305 DIAGNOSTIC ULTRASOUND DEVICE
K870878
Hitachi Medical Corp. of America
Cardiovascular · 415d
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 Feb 18, 1988
SONOLINE CF
K875272
Siemens Medical Laboratories, Inc.
Cardiovascular · 56d
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 Jun 24, 1987
MODEL 600 VASCULAR DUPLEX IMAGER
K863589
Multigon Industries, Inc.
Cardiovascular · 282d
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 Dec 22, 1986
KENZ-ECG 102
K863965
Compumed, Inc.
Cardiovascular · 73d
Cleared Jul 09, 1986
MODEL UST-SSD 880L1-5 TRANESOPHAGEAL PHASED ARRAY
K861710
Johnson & Johnson Professionals, Inc.
Cardiovascular · 65d
Cleared Mar 25, 1986
CFM-10 VINGMED COLOR FLOW MAPPING SYSTEM
K855229
Vingmed, Inc.
Cardiovascular · 85d
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 Oct 23, 1985
750 SD ULTRASOUND SCANNER(MODIFICATION)
K851901
Ultrasonix, Inc.
Cardiovascular · 176d