ClearanceBrief
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)
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Top companies in JQP

DateFirm and productCodeLinked 510(k)
Jun 30, 2014Siemens Healthcare Diagnostics, Inc.
syngo Lab Data Manager, SMN 10800057, 10803189, and 10804573.
Terminated
JQPNone listed
May 9, 2014SCC 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
JQPNone listed
Mar 31, 2014Technidata 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
JQPNone listed
Mar 19, 2014Medical 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
JQPNone listed
Mar 11, 2014Horiba 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
JQPK053308
Mar 3, 2014Medical Information Technology, Inc.
MEDITECH Microbiology - Calculator/data processing module, for clinical use.
Terminated
JQPNone listed
Jan 29, 2014GE 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
JQPNone listed
Jan 24, 2014Siemens 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
JQPNone listed
Jan 2, 2014GE 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
JQPNone listed
Dec 24, 2013Data 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
JQPNone listed
Nov 15, 2013GE 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
JQPNone listed
Jul 17, 2013Technidata S.A.
TDHistology/Cytology Classification name: Calculator/data processing module for clinical use (862.2100). Intended use: Laboratory Information System (L.I.S)
Terminated
JQPNone listed
Jun 24, 2013GE 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
JQPNone listed
May 21, 2013Technidata S.A.
TD-Synergy. Laboratory Information System.
Terminated
JQPNone listed
Apr 3, 2013Horiba 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
JQPNone listed
Jan 7, 2013Horiba Instruments, Inc dba Horiba Medical
ABX PENTRA ML, Software Versions: V8.0.x and Below; V.9.0.1 and V9.0.2
Terminated
JQPNone listed
Nov 20, 2012GE 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
JQPNone listed
Nov 6, 2012Sunquest Information Systems, Inc.
Sunquest Application Interfacing Outbound Phlebotomy Point of Care Interface, v3.0.0_07222004 and later.
Terminated
JQPNone listed
Nov 6, 2012Sunquest Information Systems, Inc.
Sunquest Laboratory, version 7.0 not available
Terminated
JQPNone listed
Oct 17, 2012Sunquest Information Systems, Inc.
Sunquest Laboratory : intended for use by professionals working in a clinical laboratory.
Terminated
JQPNone listed
Sep 7, 2012Sunquest 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
JQPNone listed
Aug 31, 2012Siemens 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
JQPNone listed
Aug 24, 2012Sunquest Information Systems, Inc.
Sunquest Laboratory LabAccess Results Workstation (LARS)
Terminated
JQPNone listed
Aug 24, 2012Sunquest Information Systems, Inc.
Sunquest Laboratory Versions 6.4 and later using Microbiology Result Entry
Terminated
JQPNone listed
Aug 22, 2012Sunquest Information Systems, Inc.
Sunquest Encompass The reporting site is using the Encompass software in an acute patient care setting.
Terminated
JQPNone listed
Aug 22, 2012Siemens 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
JQPNone listed
Aug 21, 2012Sunquest Information Systems, Inc.
Sunquest Laboratory SMART & Sunquest Laboratory SMART Select Product Usage: for clinical use
Terminated
JQPNone listed
Aug 16, 2012Sunquest Information Systems, Inc.
Sunquest Laboratory SMART & Sunquest Laboratory SMART Select
Terminated
JQPNone listed
Aug 3, 2012SCC 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
JQPNone listed
Jun 4, 2012Microsoft 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
JQPNone listed
Apr 26, 2012Medical 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
JQPNone listed
Mar 8, 2012Microsoft 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
JQPNone listed
Feb 22, 2012Microsoft 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
JQPNone listed
Jan 11, 2012Microsoft 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
JQPNone listed
Jan 11, 2012SCC 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
JQPNone listed
Jan 11, 2012SCC 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
JQPNone listed
Jan 11, 2012SCC 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
JQPNone listed
Dec 2, 2011SCC 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
JQPNone listed
Nov 21, 2011SCC 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
JQPNone listed
Nov 17, 2011SCC 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
JQPNone listed
Oct 21, 2011Data 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
JQPBK080052
Jun 14, 2011Ge 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
JQPNone listed
Feb 15, 2011Ge 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
JQPNone listed
Nov 16, 2010SCC 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
JQPNone listed
Nov 15, 2010SCC 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
JQPNone listed
Nov 10, 2010SCC 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
JQPNone listed
Oct 22, 2010Ge 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
JQPNone listed
Sep 20, 2010International Technidyne Corporation
Integrated Data Management System - Version 7.1, 7.2 and 7.3; ITC Corporation, 8 Olsen Place South, Piscataway, NJ 08854
Terminated
JQPNone listed
May 26, 2010Ge 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
JQPNone listed
Feb 26, 2010Abbott Point of Care Inc.
i-STAT HL7 Interface The HL7 Interface product is an accessory to the analyzer
Terminated
JQPK001387

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