ClearanceBrief
Panels › Cardiovascular › Product code DQK · Class 2

Computer, Diagnostic, Programmable

Regulation 870.1425

29510(k)s in 12 months (442 all time)
2recalls in 12 months (125 all time)
121recalls that name a 510(k)
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Top companies in DQK

DateFirm and productCodeLinked 510(k)
Jan 17, 2013Spacelabs Healthcare, Llc
Spacelabs Smart Disclosure System, Model 92810, is an integrated component of the Intesys Clinical Suite (ICS) G2, Version 4.03. The Smart Disclosure product collects patient waveforms, alarms, vital
Terminated
DQKK110779
Sep 12, 2012Biosense Webster, Inc.
CARTO 3 V1.05(FG-5400-00). The CARTO 3 V1.05 System is intended for catheter-based atrial and ventricular mapping. The mapping system allows real-time display of cardiac maps in a number of different
Terminated
DQKK090017
Jun 20, 2012Spacelabs Healthcare, Llc
The product is Pathfinder SL, version 1.6.0.3057 software used with the Spacelabs Healthcare Pathfinder SL Holter Analyzer, version 1.6.0. Product Usage: The Holter Analyzer analyzes information coll
Terminated
DQKK110001
May 10, 2012Siemens Medical Solutions USA, Inc
Siemens Axiom Sensis XP diagnostic programmable computer Diagnostic programmable computer
Terminated
DQKK020440
Mar 20, 2012Biosense Webster, Inc.
CARTO 3 Systems, Product Code M-4800-01 The intended use of the CARTO 3 System is catheter-based cardiac electrophysiological (EP) procedures.
Terminated
DQKK090017
K093455 +2
Jun 22, 2011Spacelabs Healthcare, Llc
Pathfinder Holter Analyzer is a Programmable Diagnostic Computer. The brochure is labeled in part: "***Pathfinder Holter Analyzer ***Spacelabs Healthcare Company Headquarters***5150 220th Ave. SE, I
Terminated
DQKK951902
Mar 28, 2011Biosense Webster, Inc.
10 ft. Interface Cable, 10 Pin - Shielded Tip Pins to 12 Pin - Blue, Manufacturing Part Number 01287-09, Catalog Number D128709. This cable is used to connect an Auto 10 10-pole catheter to an EP reco
Terminated
DQKK090017
Jan 13, 2011McKesson Provider Technologies - Medical Imaging Group
Horizon Cardiology ECG Management This is a software application designed for use in various hospital departments to import, display, store, analyze, distribute, and process ECG procedures from restin
Terminated
DQKNone listed
Aug 25, 2010Spacelabs Healthcare, Incorporated
Intesys Clinical Suite (ICS) G2 92810 Smart Disclosure. The Smart Disclosure product collects patient waveforms, alarms, vital signs and 12-lead reports. A 24-hour waveform acquisition is standard,
Terminated
DQKK063490
Jul 9, 2010McKesson Provider Technologies - Medical Imaging Group
Horizon Cardiology Hemo Component Schiller Argus Pro PB-1000 Monitor unit. Argus Pro PB 1000 firmware versions 2.41+M NIBP and 2.42.01+M. A programmable diagnostic computer intended for acquiring, di
Terminated
DQKK050561
Jun 24, 2010McKesson Provider Technologies - Medical Imaging Group
Horizon Cardiology Hemo Monitoring System A programmable diagnostic computer intended for acquiring digitizing, storing, displaying , and reviewing hemodynamic data for use in hospital cardiac cather
Terminated
DQKK050561
Aug 14, 2009GE Healthcare, LLC
GE Healthcare MUSE Cardiology Information Systems vs. 7.0, 7.0.1, 7.0.2, 7.1, 7.1.1. The MUSE Cardiology Information System is intended to store, access and manage cardiovascular information on adult
Terminated
DQKK072502
Apr 10, 2009St. Jude Medical
NurseMate with Physio Module; Remote Review, Monitoring and Charting Station; USA EPMedSystems, Inc. Cooper Run Executive Park, 575 Route 73 North, Unit D, West Berlin, NJ 08090. Outer box labeled as
Terminated
DQKK070706
Feb 5, 2008McKesson Provider Technologies
Horizon Cardiology Hemo Monitoring System;Horizon Cardiology Hemo External Control Unit;~100 - 230 VAC 50-50 Hz, Medcon Telemedicine Technology LTD.,Tel Aviv, 697190, Israel.
Terminated
DQKK050561
Aug 7, 2007General Electric Medical Systems Information Technology
GE Healthcare Systems ComboLab System. Made up of both Mac-Lab System, Software Version 6.5 2021423-015 Revision D and CardioLab System, Software Version 6.5 2021423-016 Revision D. Electrophysiolog
Terminated
DQKK050093
Aug 7, 2007General Electric Medical Systems Information Technology
GE Medical Systems CardioLab System, electrophysiological data system, Software Version 6.5 2021423-016 Revision D GE Medical Systems, Information Technologies, Inc. 8200 West Tower Avenue, Milwaukee,
Terminated
DQKK050093
Aug 7, 2007General Electric Medical Systems Information Technology
GE Medical Systems Mac-Lab System, cardiac catheterization data system. Software Version 6.5 2021423-015 Revision D GE Medical Systems, Information Technologies, Inc., 8200 West Tower Avenue, Milwauk
Terminated
DQKK050093
Nov 1, 2005Boston Scientific
Boston Scientific brand Signal Acquisition Module (SAM), a Realtime Position Management (RPM) System, Catalog/Model Numbers: 8300
Terminated
DQKK992912
Oct 22, 2004Siemens Medical Solutions USA, Inc
AXIOM Sensis Programmable diagnostic computer, Model number 66 48 161
Terminated
DQKK020440
Oct 22, 2004Siemens Medical Solutions USA, Inc
AXIOM Sensis Programmable diagnostic computer, Model number 66 34 658
Terminated
DQKK020440
Oct 22, 2004Siemens Medical Solutions USA, Inc
AXIOM Sensis Programmable diagnostic computer, Model number 66 34 641
Terminated
DQKK020440
Oct 22, 2004Siemens Medical Solutions USA, Inc
AXIOM Sensis Programmable diagnostic computer, Model number 66 34 633.
Terminated
DQKK020440
Oct 22, 2004Siemens Medical Solutions USA, Inc
AXIOM Sensis Programmable diagnostic computer, Model number 66 23 974.
Terminated
DQKK020440
Sep 14, 2004Siemens Medical Solutions USA, Inc
AXIOM Sensis Report Workstation. Programmable diagnostic computer. Model number 6627637
Terminated
DQKK020440
Jul 3, 2003Siemens Medical Solutions USA, Inc
Axiom Sensis. Programmable Diagnostic Computer
Terminated
DQKK020440

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