DXK · Class II · 21 CFR 870.2330

FDA Product Code DXK: Echocardiograph

Leading manufacturers include Hewlett-Packard Co., Boston Scientific Corporation and Siemens Medical Solutions USA, Inc..

78
Total
78
Cleared
115d
Avg days
1977
Since

FDA 510(k) Cleared Echocardiograph Devices (Product Code DXK)

78 devices
1–24 of 78
Cleared May 17, 2018
Ultra ICE Plus – PI 9 MHz Peripheral Imaging Catheter
K181042
Boston Scientific Corporation
Cardiovascular · 28d
Cleared Feb 26, 2016
Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter(eDFU), Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter (Paper DFU)
K160173
Boston Scientific Corporation
Cardiovascular · 30d
Cleared Apr 22, 1991
MODIFIED SYST: SONOS 500/1000 ULTRSOUND IMAG SYST
K904832
Hewlett-Packard Co.
Cardiovascular · 181d
Cleared Mar 02, 1988
RT5000 W/QUANTI. SPEC. DOPPLER, CW DOPP. MODIFICA.
K871555
General Electric Co.
Cardiovascular · 315d
Cleared Feb 18, 1988
SERIES 77000 ULTRASOUND IMAGING SYSTEM
K873762
Hewlett-Packard Co.
Cardiovascular · 155d
Cleared Jul 09, 1986
MODEL UST-SSD 880L1-5 TRANESOPHAGEAL PHASED ARRAY
K861710
Johnson & Johnson Professionals, Inc.
Cardiovascular · 65d
Cleared Mar 10, 1986
SONOLINE SX ULTRASOUND SCANNER
K852739
Siemens Medical Solutions USA, Inc.
Cardiovascular · 256d
Cleared Oct 31, 1985
IRREGULAR CURVE TRACING REVISITION & DOPPLER
K853769
Hewlett-Packard Co.
Cardiovascular · 52d
Cleared Mar 22, 1978
CATHODE RAY TUBE DISPLAY MODEL 1340A
K780332
Hewlett-Packard Co.
Radiology · 22d

About Product Code DXK - Regulatory Context