Panels › Clinical Chemistry › Product code JQP · Class 1
Calculator/Data Processing Module, For Clinical Use
Regulation 862.2100
0510(k)s in 12 months (78 all time)
2recalls in 12 months (218 all time)
17recalls that name a 510(k)
Top companies in JQP
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 30, 2014 | Siemens Healthcare Diagnostics, Inc. syngo Lab Data Manager, SMN 10800057, 10803189, and 10804573. Terminated |
JQP | None listed |
| May 9, 2014 | SCC Soft Computer SCC SA HIS version 4.0.7.0 when used with SoftMic version 4.0.7.0.
SoftMic is a laboratory information system to be used in medical results, clinical, and public health laboratories by knowledgeable Terminated |
JQP | None listed |
| Mar 31, 2014 | Technidata S.A. TDWorkstation version 11.01.A or higher. TDWorkstation Evolution.
TDWorkstation receives patient results from a connected instrument and sends them to a Laboratory Information System (LIS). Terminated |
JQP | None listed |
| Mar 19, 2014 | Medical Information Technology, Inc. MEDITECH Microbiology; Client Server Releases 5.6, 5.65, 5.66, 5.67, 6.0, 6.05, 6.07, 6.1, 6.13 and 6.14.
Integrates requisition, specimen processing, and patient information with data in the healthc Terminated |
JQP | None listed |
| Mar 11, 2014 | Horiba Instruments, Inc dba Horiba Medical Device Name: ABX PENTRA ML
Model/Part #(s): A11A01652
Lot/Serial #(s): N/A
Software Version(s): All versions are subject to this correction.
Product Usage:
The ABX PENTRA ML is a software data manag Terminated |
JQP | K053308 |
| Mar 3, 2014 | Medical Information Technology, Inc. MEDITECH Microbiology - Calculator/data processing module, for clinical use. Terminated |
JQP | None listed |
| Jan 29, 2014 | GE Healthcare It The Centricity Laboratory System is intended to be an information system designed to support the clinical and administrative activities associated with the provision and utilization of clinical labora Terminated |
JQP | None listed |
| Jan 24, 2014 | Siemens Healthcare Diagnostics, Inc. Siemens CentraLink" Data Management System V14.0.4, V14.0.5 or V14.0.8
The CentraLink system software is a network solution provider and multi-system data manager for the instruments and lab automati Terminated |
JQP | None listed |
| Jan 2, 2014 | GE Healthcare It The Centricity Laboratory System is intended to be an information system designed to support the clinical and administrative activities associated with the provision and utilization of clinical labora Terminated |
JQP | None listed |
| Dec 24, 2013 | Data Innovations, Inc. Instrument Manager driver : Driver sysu100i that connects to the Sysmex UF-100 analyzer
Software all versions prior to( v7.00.0006 and v8.00.0005): v7.00.0001, v7.00.0002, v7.00.0003, v7.00.0004, v7. Terminated |
JQP | None listed |
| Nov 15, 2013 | GE Healthcare It The Centricity Laboratory System is intended to be an information system designed to support the clinical and administrative activities associated with the provision and utilization of clinical labora Terminated |
JQP | None listed |
| Jul 17, 2013 | Technidata S.A. TDHistology/Cytology
Classification name: Calculator/data processing module for clinical use (862.2100). Intended use: Laboratory Information System (L.I.S) Terminated |
JQP | None listed |
| Jun 24, 2013 | GE Healthcare It The Centricity Laboratory System is intended to be an information system designed to support the clinical and administrative activities associated with the provision and utilization of clinical labora Terminated |
JQP | None listed |
| May 21, 2013 | Technidata S.A. TD-Synergy.
Laboratory Information System. Terminated |
JQP | None listed |
| Apr 3, 2013 | Horiba Instruments, Inc dba Horiba Medical ABX Micros IM2, Part# M60CSB110EN04 and D00A00202
The IM2 Data Management System consists of the IM2 Data Manager Software, Desktop Computer, keyboard, mouse, and a unidirectional serial cable. The I Terminated |
JQP | None listed |
| Jan 7, 2013 | Horiba Instruments, Inc dba Horiba Medical ABX PENTRA ML, Software Versions: V8.0.x and Below; V.9.0.1 and V9.0.2 Terminated |
JQP | None listed |
| Nov 20, 2012 | GE Healthcare It Centricity Laboratory Core Lab System 4.1
The Centricity Laboratory System is intended to be an information system designed to support the clinical and administrative activities associated with the p Terminated |
JQP | None listed |
| Nov 6, 2012 | Sunquest Information Systems, Inc. Sunquest Application Interfacing Outbound Phlebotomy Point of Care Interface, v3.0.0_07222004 and later. Terminated |
JQP | None listed |
| Nov 6, 2012 | Sunquest Information Systems, Inc. Sunquest Laboratory, version 7.0
not available Terminated |
JQP | None listed |
| Oct 17, 2012 | Sunquest Information Systems, Inc. Sunquest Laboratory :
intended for use by professionals working in a clinical laboratory. Terminated |
JQP | None listed |
| Sep 7, 2012 | Sunquest Information Systems, Inc. Sunquest Laboratory
Sunquest Laboratory is intended for use by professionals working in a clinical laboratory. Sunquest Laboratory is intended for use only by professionals who have received extensiv Terminated |
JQP | None listed |
| Aug 31, 2012 | Siemens Healthcare Diagnostics, Inc. syngo(R) Lab Data Manager and syngo(R) Lab Process Manager, all versions.
This device is classified as a data calculator and processing module for use with In-vitro diagnostic devices. It also provid Terminated |
JQP | None listed |
| Aug 24, 2012 | Sunquest Information Systems, Inc. Sunquest Laboratory LabAccess Results Workstation (LARS) Terminated |
JQP | None listed |
| Aug 24, 2012 | Sunquest Information Systems, Inc. Sunquest Laboratory Versions 6.4 and later using Microbiology Result Entry Terminated |
JQP | None listed |
| Aug 22, 2012 | Sunquest Information Systems, Inc. Sunquest Encompass
The reporting site is using the Encompass software in an acute patient care setting. Terminated |
JQP | None listed |
| Aug 22, 2012 | Siemens Healthcare Diagnostics, Inc. EasyLink Informatic System is included with the Dimension Vista System. The Dimension Vista Integrated System is an in vitro diagnostic device intended tot duplicate manual analytical procedures such Terminated |
JQP | None listed |
| Aug 21, 2012 | Sunquest Information Systems, Inc. Sunquest Laboratory SMART & Sunquest Laboratory SMART Select
Product Usage: for clinical use Terminated |
JQP | None listed |
| Aug 16, 2012 | Sunquest Information Systems, Inc. Sunquest Laboratory SMART & Sunquest Laboratory SMART Select Terminated |
JQP | None listed |
| Aug 3, 2012 | SCC Soft Computer SoftLab with SA INST versions: 3.1.6.12, 4.0.1.26-4.0.1.32, 4.0.2.21-4.0.2.51, and 4.0.3.5-4.0.3.13.
Product UsageSoftLab is a laboratory information system to be used in a medical research or clini Terminated |
JQP | None listed |
| Jun 4, 2012 | Microsoft Corporation Health Solutions Group Microsoft Amalga UIS 2009 (previously known as Microsoft Amalga Unified Intelligence System), Calculator/data processing module, for clinical use.
Microsoft Amalga UIS 2009 enables healthcare provid Terminated |
JQP | None listed |
| Apr 26, 2012 | Medical Information Technology, Inc. MEDITECH Anatomical Pathology Software Client Releases-
Client Service Releases 5.6, 5.63, 5.64, 5.65, 6.0, 6.04, 6.05, 6.06, 6.1, 6.12 and 6.13
Product Usage:
Meditech Anatomical Pathology Software Terminated |
JQP | None listed |
| Mar 8, 2012 | Microsoft Corporation Health Solutions Group Microsoft Amalga UIS 2009 is Microsoft Amalga Unified Intelligence System (UIS), Calculator/data processing module, for clinical use.
Microsoft Amalga UIS 2009 enables healthcare providers to create Terminated |
JQP | None listed |
| Feb 22, 2012 | Microsoft Corporation Health Solutions Group Microsoft Amalga - previously known as Microsoft Amalga Unified Intelligence System (UIS) 2009
Product Usage:
Microsoft Amalga UIS 2009 enables healthcare providers to create a comprehensive continua Terminated |
JQP | None listed |
| Jan 11, 2012 | Microsoft Corporation Health Solutions Group Microsoft Amalga Unified Intelligence System (UIS), This is a software-only device, WHIE Implementation v1.1i. A calculator/data processing module, for clinical use.
Intended to provide the clinical Terminated |
JQP | None listed |
| Jan 11, 2012 | SCC Soft Computer SoftMic GUI versions: 4.0.3.0-4.0.3.15, 4.0.4.1-4.0.4.7.
SoftMic is a laboratory information system to be used in medical research, clinical, and public health laboratories by knowledgeable, trained, Terminated |
JQP | None listed |
| Jan 11, 2012 | SCC Soft Computer SoftLab used with SA INST 4.0.2.0 to 4.0.2.51, 4.0.3.0 to 4.0.3.13, 4.5.0.0 to 4.5.0.9, 4.5.2.0 to 4.5.2.8 and SA INST 3.1.3.0 to 3.1.3.29, 3.1.6.0 to 3.1.6.17, 4.0.0.0, 4.0.1.0 to 4.0.1.32.
SoftLab Terminated |
JQP | None listed |
| Jan 11, 2012 | SCC Soft Computer SoftLab GUI versions: 3.18.1.0-3.18.1.21; 3.19.1.0-3.19.1.25; 3.19.2.0-3.19.2.21; 4.0.0.2; 4.0.1.0-4.0.1.16; 4.0.2.0-4.0.2.10; 4.0.3.0-4.0.3.16; 4.0.4.0-4.0.4.6; and 4.5.0.0-4.5.0.8.
Product Usage: Terminated |
JQP | None listed |
| Dec 2, 2011 | SCC Soft Computer SoftPath GUI versions: 4.2.3.3-4.2.3.6 and 4.3.0.5-4.3.0.12.
SoftPath is a laboratory information system to be used in a clinical laboratory by knowledgeable, trained, and experienced personnel. Soft Terminated |
JQP | None listed |
| Nov 21, 2011 | SCC Soft Computer Software: SA BASE 3.1.4.x, 3.1.6.x and SA LabMic 4.0.0.x, 4.0.1.x, 4.0.2.x, 4.0.3.x, 4.0.4.x.
SoftLab is a laboratory information system to be used in a medical research or clinical laboratory by Terminated |
JQP | None listed |
| Nov 17, 2011 | SCC Soft Computer SoftPath GUI versions: 3.17.5 to 3.17.9, 4.2.1 to 4.2.3, and 4.3.0 to 4.3.0.4.
SoftPath is a laboratory information system to be used in a clinical laboratory by knowledgeable, trained, and experien Terminated |
JQP | None listed |
| Oct 21, 2011 | Data Innovations, Inc. Instrument Manager -Software Versions 8.05, 8.06, 8.07, 8.08, and 8.09.
It is a stand-alone software package that provides connectivity between laboratory instruments and Laboratory Information Syst Terminated |
JQP | BK080052 |
| Jun 14, 2011 | Ge Healthcare It GE Centricity Laboratory Instrument Interface to Data Innovations Instrument Manager software; GE Healthcare IT Solutions, Barrington, IL 60010.
The Centricity Laboratory is designed to facilitate t Terminated |
JQP | None listed |
| Feb 15, 2011 | Ge Healthcare It GE Centricity Laboratory software; GE Healthcare IT, Barrington, IL 60010. The intended use: the Centricity Laboratory is used to facilitate the general clinical, anatomic pathology and cytology labor Terminated |
JQP | None listed |
| Nov 16, 2010 | SCC Soft Computer SoftLab GUI Version 4.0.1.0 - 4.0.1.16, 4.0.2.0 - 4.0.2.10, 4.0.3.0 - 4.0.3.13, and 4.0.4.0 - 4.0.4.5.
SCC Soft Computer 5400 Tech Data Drive Clearwater, FL 33760.
Manufacture/Distribution Dates:
Terminated |
JQP | None listed |
| Nov 15, 2010 | SCC Soft Computer SA BASE with SoftLab Version 3.1.4.x.
Manufactured 03/2003.
SCC Soft Computer 5400 Tech Data Drive Clearwater, FL 33760.
Intends to provide clients with an interface that links all clinical labo Terminated |
JQP | None listed |
| Nov 10, 2010 | SCC Soft Computer SoftLab/Mic ASCII Add-on Versions 4.0.1.14, 4.0.1.15, and 4.0.1.16.
SCC Soft Computer 5400 Tech Data Drive Clearwater, FL 33760.
Version 4.0.1.14 Manufactured & Distributed 12/29/2006.
Version 4.0 Terminated |
JQP | None listed |
| Oct 22, 2010 | Ge Healthcare It GE Centricity Laboratory Instrument Interface software; GE Healthcare Integrated IT Solutions, Barrington, IL 60010. The intended use: the Centricity Laboratory is used to facilitate the general clini Terminated |
JQP | None listed |
| Sep 20, 2010 | International Technidyne Corporation Integrated Data Management System - Version 7.1, 7.2 and 7.3;
ITC Corporation, 8 Olsen Place South, Piscataway, NJ 08854 Terminated |
JQP | None listed |
| May 26, 2010 | Ge Healthcare It GE Centricity Laboratory software; GE Healthcare Integrated IT Solutions, Barrington, IL 60010. The intended use: the Centricity Laboratory is used to facilitate the general clinical, anatomic patholo Terminated |
JQP | None listed |
| Feb 26, 2010 | Abbott Point of Care Inc. i-STAT HL7 Interface
The HL7 Interface product is an accessory to the analyzer Terminated |
JQP | K001387 |
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