FDA.reportPublic FDA data

Sunquest VUE

Primary DI
B236VUE202210
Brand
Sunquest VUE
Company
CliniSys, Inc
Model
2022.1
Device description
The intended use of Sunquest VUE is to support laboratories in the management of patient reports and to transfer, store, and display test results and information.
Published
2022-12-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
NVVDigital Image, Storage And Communications, Non-Diagnostic, Laboratory Information System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NVVDigital Image, Storage And Communications, Non-Diagnostic, Laboratory Information SystemClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B236VUE202210PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Pathology information system application softwareAn application software program, routines, and/or algorithms intended to be used as or in an information system to electronically receive, collect, store, manage, assist in analysis of, display, output, and distribute data, within or between healthcare facilities, to support the administrative and clinical activities associated with the provision and utilization of pathology services and facilities. It is typically supplied for installation into a dedicated pathology information system or existing mainframe or decentralized computers/networks.

Regulatory Flags#

DUNS number
052934841
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B236CPP8030Clinisys CoPathPlus8.0.32026-02-18
B236SQBB202420Clinisys SQ Blood Bank2024.22026-01-23
B236SQLAB202420Clinisys SQ Lab2024.22026-01-23
B236CATL202510Clinisys Atlas2025.12026-01-06
B236CLS202520Clinisys Laboratory Solution2025.22025-11-10
B236CLS202510Clinisys Laboratory Solution2025.12025-08-13
B236CATL202350Clinisys Atlas2023.52025-07-11
B236BB10110Sunquest Blood Bank10.1.12022-03-22
B236LAB10110Sunquest Laboratory10.1.12022-03-22
B236BB10010Sunquest Blood Bank10.0.12021-03-05
B236LAB10010Sunquest Laboratory10.0.12021-03-05
B236BB8010Sunquest Blood Bank8.0.12021-02-19
B236BB8130Sunquest Blood Bank8.1.32021-02-19
B236BB8230Sunquest Blood Bank8.2.32021-02-19
B236LAB8010Sunquest Laboratory8.0.12021-02-19
B236LAB8130Sunquest Laboratory8.1.32021-02-19
B236LAB8230Sunquest Laboratory8.2.32021-02-19
B236SQBB202410Clinisys SQ Blood Bank2024.12024-12-06
B236SQLAB202410Clinisys SQ Lab2024.12024-12-06
B236CATL202340Clinisys Atlas2023.42024-11-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B236CPP8030Clinisys CoPathPlusCliniSys, IncNVV2026-02-18
00860009458109SentinelVistapath Biosystems, Inc.NVV2023-05-01
04049016135210EUROLabOffice 4.0EUROIMMUN Medizinische Labordiagnostika AGNVV2022-12-08
B433CL0CyberLABASPYRA, LLCNVV2022-10-12
B236PWP13000Sunquest PowerPathCliniSys, IncNVV2022-04-14
B236CPP8000Sunquest CoPathPlusCliniSys, IncNVV2022-03-28
00859474006663SoftMediaSCC SOFT COMPUTERNVV2020-12-09
00859474006472SoftMediaSCC SOFT COMPUTERNVV2020-12-04
B236CPP7100Sunquest CoPathPlusCliniSys, IncNVV2020-11-12
B236PWP12000Sunquest PowerPathCliniSys, IncNVV2020-11-12
00859474006465SoftMediaSCC SOFT COMPUTERNVV2020-04-29
00859474006410SoftMediaSCC SOFT COMPUTERNVV2020-01-25
00859474006403SoftMediaSCC SOFT COMPUTERNVV2019-11-12
00859474006373SoftMediaSCC SOFT COMPUTERNVV2019-11-08
05060508820024ULTRA Laboratory Information SystemCIRDAN IMAGING LIMITEDNVV2019-10-08
08800019600121Imaging System HIS-5000UHuvitz Co., Ltd.NVV2019-05-10
00859474006366SoftMediaSCC SOFT COMPUTERNVV2019-03-15
00859474006342SoftMediaSCC SOFT COMPUTERNVV2018-12-08
00859474006298SoftMediaSCC SOFT COMPUTERNVV2018-07-21
00859474006250SoftMediaSCC SOFT COMPUTERNVV2018-04-04
00859474006212SoftMediaSCC SOFT COMPUTERNVV2018-01-19
00859474006182SoftMediaSCC SOFT COMPUTERNVV2017-10-26
00859474006144SoftMediaSCC SOFT COMPUTERNVV2017-07-15
00859474006106SoftMediaSCC SOFT COMPUTERNVV2017-05-13