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
73–78 of 78
Cleared Jan 17, 1980
SONACOLOR 6000
K792540
Carolina Medical Electronics
Cardiovascular · 38d
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
Cleared Jan 25, 1977
PRIMUS INTER PARESECHOCARDIOGRAPHY SYS.
K770073
Rohe Scientific Corp.
Cardiovascular · 12d