FDA.reportPublic FDA data

Vidar Systems Corporation

Primary DI
00851194002147
Brand
Vidar Systems Corporation
Company
VIDAR SYSTEMS CORPORATION
Model
MASTER CD, CLINICAL EXPRESS 6.1 BUILD 15
Catalog number
19206-006
Published
2016-09-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
LMADigitizer, Image, Radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LMADigitizer, Image, RadiologicalRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851194002147PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851194002147008511940021478511940021470851194002147

GMDN Terms#

Term, Definition table
TermDefinition
Radiology DICOM image processing application softwareA software application intended to facilitate management, distribution, and/or viewing of radiological digital imaging and communications in medicine (DICOM) image data; it is not intended for pathological image interpretation (i.e., not intended to detect and localize suspected abnormalities). It may be intended to facilitate image management (e.g., viewing, communication, printing, recording/ disc burning) and/or image manipulation and quantification (e.g., non-interpretive graphical overlays).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
130234743
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851194002000Vidar Systems CorporationDiagnosticPRO Advantage16323-0062016-09-25
00851194002017Vidar Systems CorporationDosimetryPRO Advantage, Red Illumination17500-0012016-09-25
00851194002031Vidar Systems CorporationSierra Advantage Single Sheet14048-0102016-09-25
00851194002048Vidar Systems CorporationSierra Advantage Multi Sheet14050-0102016-09-25
00851194002093Vidar Systems CorporationCADPRO Advantage with D Feeder19094-0012016-09-25
00851194002109Vidar Systems CorporationDental Film Digitizer18800-0022016-09-25
00851194002116Vidar Systems CorporationTeleradPRO Edge HD-CCD SF19510-0012016-09-25
00851194002123Vidar Systems CorporationTeleradPRO Edge HD-CCD MF19511-0012016-09-25
00851194002130Vidar Systems CorporationDiagnosticPRO Edge19523-0012016-09-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04056481140502Patient Data ManagerBrainlab SELMA2018-06-15
04056481138615PATIENT DATA MANAGER 2.4 INSTALLERBrainlab SELMA2018-02-09
04056481132453Origin Data Management / Patient Data ManagerBrainlab SELMA2017-01-02
00850677007082MDR Video TouchHYLAND LLCLMA2016-09-26
00851194002000Vidar Systems CorporationVIDAR SYSTEMS CORPORATIONLMA2016-09-25
00851194002017Vidar Systems CorporationVIDAR SYSTEMS CORPORATIONLMA2016-09-25
00851194002031Vidar Systems CorporationVIDAR SYSTEMS CORPORATIONLMA2016-09-25
00851194002048Vidar Systems CorporationVIDAR SYSTEMS CORPORATIONLMA2016-09-25
00851194002093Vidar Systems CorporationVIDAR SYSTEMS CORPORATIONLMA2016-09-25
00851194002109Vidar Systems CorporationVIDAR SYSTEMS CORPORATIONLMA2016-09-25
00851194002116Vidar Systems CorporationVIDAR SYSTEMS CORPORATIONLMA2016-09-25
00851194002123Vidar Systems CorporationVIDAR SYSTEMS CORPORATIONLMA2016-09-25
00851194002130Vidar Systems CorporationVIDAR SYSTEMS CORPORATIONLMA2016-09-25
00866389000167Radlink Laser Pro 16RADLINK, INC.LMA2016-09-21
00850677007068MDR Video CartHYLAND LLCLMA2016-09-19
00850677007075MDR Video SpeechHYLAND LLCLMA2016-09-19
00850677007020MDR VideoHYLAND LLCLMA2016-09-16
00850677007037Dicom BoxHYLAND LLCLMA2016-09-16
04056481006662Origin Data Management / Patient Data ManagerBrainlab SELMA2016-09-15