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)
Top companies in DQK
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 17, 2013 | Spacelabs 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 |
DQK | K110779 |
| Sep 12, 2012 | Biosense 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 |
DQK | K090017 |
| Jun 20, 2012 | Spacelabs 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 |
DQK | K110001 |
| May 10, 2012 | Siemens Medical Solutions USA, Inc Siemens Axiom Sensis XP diagnostic programmable computer
Diagnostic programmable computer Terminated |
DQK | K020440 |
| Mar 20, 2012 | Biosense 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 |
DQK | K090017 K093455 +2 |
| Jun 22, 2011 | Spacelabs 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 |
DQK | K951902 |
| Mar 28, 2011 | Biosense 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 |
DQK | K090017 |
| Jan 13, 2011 | McKesson 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 |
DQK | None listed |
| Aug 25, 2010 | Spacelabs 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 |
DQK | K063490 |
| Jul 9, 2010 | McKesson 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 |
DQK | K050561 |
| Jun 24, 2010 | McKesson 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 |
DQK | K050561 |
| Aug 14, 2009 | GE 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 |
DQK | K072502 |
| Apr 10, 2009 | St. 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 |
DQK | K070706 |
| Feb 5, 2008 | McKesson 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 |
DQK | K050561 |
| Aug 7, 2007 | General 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 |
DQK | K050093 |
| Aug 7, 2007 | General 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 |
DQK | K050093 |
| Aug 7, 2007 | General 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 |
DQK | K050093 |
| Nov 1, 2005 | Boston Scientific Boston Scientific brand Signal Acquisition Module (SAM), a Realtime Position Management (RPM) System, Catalog/Model Numbers: 8300 Terminated |
DQK | K992912 |
| Oct 22, 2004 | Siemens Medical Solutions USA, Inc AXIOM Sensis Programmable diagnostic computer, Model number 66 48 161 Terminated |
DQK | K020440 |
| Oct 22, 2004 | Siemens Medical Solutions USA, Inc AXIOM Sensis Programmable diagnostic computer, Model number 66 34 658 Terminated |
DQK | K020440 |
| Oct 22, 2004 | Siemens Medical Solutions USA, Inc AXIOM Sensis Programmable diagnostic computer, Model number 66 34 641 Terminated |
DQK | K020440 |
| Oct 22, 2004 | Siemens Medical Solutions USA, Inc AXIOM Sensis Programmable diagnostic computer, Model number 66 34 633. Terminated |
DQK | K020440 |
| Oct 22, 2004 | Siemens Medical Solutions USA, Inc AXIOM Sensis Programmable diagnostic computer, Model number 66 23 974. Terminated |
DQK | K020440 |
| Sep 14, 2004 | Siemens Medical Solutions USA, Inc AXIOM Sensis Report Workstation. Programmable diagnostic computer. Model number 6627637 Terminated |
DQK | K020440 |
| Jul 3, 2003 | Siemens Medical Solutions USA, Inc Axiom Sensis. Programmable Diagnostic Computer Terminated |
DQK | K020440 |
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