FDA.reportPublic FDA data

SoftMedia

Primary DI
00859474006366
Brand
SoftMedia
Company
SCC SOFT COMPUTER
Model
3.2.7.310
Published
2019-03-15
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
00859474006366PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00859474006366008594740063668594740063660859474006366

GMDN Terms#

Term, Definition table
TermDefinition
Clinical laboratory information system application softwareAn application software program, routines, and/or algorithms 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 clinical laboratory services and facilities. It is typically supplied for installation into a dedicated information system used in the clinical laboratory or existing mainframe or decentralized computers/networks.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
131311409
Device count
1
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810142373012SoftPath4.4.7.42026-05-29
00810142374064SoftBiobank1.0.1.132026-05-05
00810142373807SoftBank25.6.3.12026-04-29
00810142373975SoftBiochemistry4.3.0.22026-04-16
00810142373982SoftCytogenetics4.3.0.22026-04-16
00810142373999SoftPathDx4.3.0.22026-04-16
00810142374002SoftFlowCytometry4.3.0.22026-04-16
00810142374019SoftHLA4.3.0.22026-04-16
00810142374026SoftMolecular4.3.0.22026-04-16
00810142374033SoftGenomics4.3.0.22026-04-16
00810142374040SoftTrack4.3.0.22026-04-16
00810142373586SoftTotalQC1.0.11.12026-03-28
00810142373715SoftBiochemistry4.3.0.12026-03-12
00810142373722SoftCytogenetics4.3.0.12026-03-12
00810142373739SoftPathDx4.3.0.12026-03-12
00810142373746SoftFlowCytometry4.3.0.12026-03-12
00810142373753SoftHLA4.3.0.12026-03-12
00810142373760SoftMolecular4.3.0.12026-03-12
00810142373777SoftGenomics4.3.0.12026-03-12
00810142373784SoftTrack4.3.0.12026-03-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B236CPP8030Clinisys CoPathPlusCliniSys, IncNVV2026-02-18
00860009458109SentinelVistapath Biosystems, Inc.NVV2023-05-01
B236VUE202210Sunquest VUECliniSys, IncNVV2022-12-19
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
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