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Radlink Laser Pro 16

Primary DI
00866389000167
Brand
Radlink Laser Pro 16
Company
RADLINK, INC.
Model
LP100
Device description
The Radlink Laser Pro 16 is a film digitization system that follows a three-step process of acquiring, selecting, and sending digitized films to any desired destination. A laser beam light source and a sealed optic path are used to scan the film that is driven by a clocked, stepping motor. It utilizes a 12-film auto loader, and its software provides image quality control and post-processing functions and enables distribution and routing of DICOM images through a healthcare network.
Published
2016-09-21
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K020243000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K020243000LASERPRO 16Eradlink, Inc.2002-03-05LMA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00866389000167PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00866389000167008663890001678663890001670866389000167

GMDN Terms#

Term, Definition table
TermDefinition
Radiography digital imaging scannerA laser or light-based optical unit designed to convert medical images originally captured on x-ray film or phosphor storage plate (PSP) into a digital format. Examples of this device include devices employing video frame grabbers, and scanners which use lasers or charge-coupled devices. Depending on the design, the digitized images can then be digitally transferred from location to location, archived, or used with other digital image processing, analysis or recording systems.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
069190036
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00864908000131Radlink PH GPS BracketPH BRACKET2019-06-21
00864908000148Radlink GPS Tablet/Monitor StandM STAND2019-06-21
00864908000162Radlink GPS TraumaGPS Trauma2019-06-21
00864908000100Radlink DR Tablet RetrofitDRRETRO2016-12-06
00864908000124Radlink GPS Tablet StandSTAND2018-01-31
00866389000105Radlink GPS 2200GPS22002016-09-21
00866389000129Radlink Wireless C-Arm KitC-Arm Kit2016-09-21
00866389000143Radlink DR Pro 2200DR22002016-09-21
00866389000150Radlink CR Pro 2200CR201-12016-09-21
00866389000181Radlink CassetteCAS10122016-09-21
00866389000198Radlink CassetteCAS14172016-09-21
00864908000117Radlink PACSPACS-SW2017-01-24
00866389000112Radlink GPS Tablet 2200TABLET2016-09-21
00866389000136Radlink GPS Bucky CartBucky2016-09-21
00866389000174Radlink SensorSENSOR2016-09-21

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
00851194002147Vidar Systems CorporationVIDAR SYSTEMS CORPORATIONLMA2016-09-25
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