DQK · Class II · 21 CFR 870.1425

FDA Product Code DQK: Computer, Diagnostic, Programmable

FDA product code DQK covers programmable diagnostic computers used in cardiovascular medicine.

These systems acquire, process, and analyze cardiovascular signals — including ECG, hemodynamic data, and intracardiac electrograms — to support diagnosis and treatment decisions. They are used in cardiac catheterization labs, electrophysiology suites, and intensive care units.

DQK devices are Class II medical devices, regulated under 21 CFR 870.1425 and reviewed by the FDA Cardiovascular panel.

Leading manufacturers include Biosense Webster, Inc., St Jude Medical and Abbott Medical.

434
Total
434
Cleared
141d
Avg days
1976
Since
434 devices
193–216 of 434
Cleared Mar 15, 2007
SPACELABS MEDICAL FULL DISCLOSURE SYSTEM, MODEL 91810
K063490
Spacelabs Medical, Inc.
Cardiovascular · 118d
Cleared Sep 15, 2006
MAC-LAB/CARDIOLAB /COMBOLAB/SPECIALSLAB SYSTEM
K061741
Ge Healthcare
Cardiovascular · 87d
Cleared Mar 09, 2006
NOGA XP CARDIAC NAVIGATION SYSTEM WITH QWIKMAP SOFTWARE
K053194
Biosense Webster, Inc.
Cardiovascular · 114d
Cleared Jan 13, 2006
DATEX-OHMEDA S/5 CARDIAC OUTPUT MODULE, E-COP AND ACCESSORIES
K052976
Ge Healthcare
Cardiovascular · 81d
Cleared Nov 22, 2005
DATEX-OHMEDA S/5 CARDIAC OUTPUT AND SVO2 MODULE, E-COPSV AND ACCESSORIES
K052977
Ge Healthcare
Cardiovascular · 29d
Cleared Sep 29, 2005
CARTO RMT EP NAVIGATION SYSTEM
K042681
Biosense Webster, Inc.
Cardiovascular · 365d
Cleared Jul 19, 2005
MARS HOLTER ANALYSIS WORKSTATION
K051026
Ge Medical Systems Information Technologies
Cardiovascular · 88d
Cleared May 13, 2005
MAC-LAB/CARDIOLAB EP/COMBOLAB SYSTEM
K050093
Ge Medical Systems Information Technologies
Cardiovascular · 119d
Cleared Apr 05, 2005
MUSE CARDIOLOGY INFORMATION SYSTEM
K050614
Ge Medical Systems Information Technologies
Cardiovascular · 26d
Cleared Mar 21, 2005
CARTO XP EP NAVIGATION SYSTEM, SOFTWARE VERISON 8
K042999
Biosense Webster, Inc.
Cardiovascular · 140d
Cleared Oct 20, 2004
SYNESCOPE, EASYSCOPE, SYNECOM, HOLTERREADER
K042002
Ela Medical, Inc.
Cardiovascular · 86d
Cleared Oct 30, 2003
T-WAVE ALTERNANS (TWA) ALGORITHM OPTION
K032513
Ge Medical Systems Information Technologies
Cardiovascular · 77d
Cleared Oct 10, 2003
MODIFICATION TO: MAC-LAB/CARDIOLAB EP/COMBOLAB SYSTEM
K032577
Ge Medical Systems Information Technologies
Cardiovascular · 50d
Cleared Sep 09, 2003
INFINITY MEGACARE
K031970
Siemens Medical Solutions USA, Inc.
Cardiovascular · 75d
Cleared Sep 05, 2003
PYRAMIS ECG MANAGEMENT SYSTEM MODEL NUMBERS, 92600 AND 92601
K032038
Quinton, Inc.
Cardiovascular · 66d
Cleared Aug 01, 2003
CARDIOSOFT/CASE CARDIAC TESTING SYSTEM
K031561
Ge Medical Systems Information Technologies
Cardiovascular · 74d
Cleared Jun 03, 2003
LABSYSTEM III EP LABORATORY W/WINDOWS PLATFORM & WINDOWS EP SOFTWARE VERSION 1.0
K031000
C.R. Bard, Inc.
Cardiovascular · 64d
Cleared Jan 09, 2003
CARTO XP AND QWIKMAP EP NAVIGATION SYSTEM
K020863
Biosense Webster, Inc.
Cardiovascular · 297d
Cleared Sep 04, 2002
QUINTON Q-CATH, MODEL 000460
K021906
Quinton, Inc.
Cardiovascular · 86d
Cleared Nov 21, 2001
CARTO XP EP NAVIGATION SYSTEM
K013083
Biosense Webster, Inc.
Cardiovascular · 68d
Cleared May 02, 2001
SYNETEC
K002817
Ela Medical, Inc.
Cardiovascular · 233d
Cleared Mar 01, 2001
ASTRONOMER+WITH SLD
K003362
Boston Scientific Corp
Cardiovascular · 125d
Cleared Oct 05, 2000
CATHCOR DESKTOP
K002137
Siemens Elema AB
Cardiovascular · 83d
Cleared May 05, 2000
MODIFICATION TO CARTO EP NAVIGATION SYSTEM
K000190
Biosense Webster, Inc.
Cardiovascular · 113d