FDA.reportPublic FDA data

Radlink PACS

Primary DI
00864908000117
Brand
Radlink PACS
Company
RADLINK, INC.
Model
PACS-SW
Device description
The Radlink Picture Archiving and Communication System (PACS) is an external server for storage and retrieval of varying modality images and their corresponding information.
Published
2017-01-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
LLZSystem, Image Processing, Radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LLZSystem, Image Processing, RadiologicalRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00864908000117PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00864908000117008649080001178649080001170864908000117

GMDN Terms#

Term, Definition table
TermDefinition
Radiology picture archiving and communication system digital archive deviceA mains electricity (AC-powered) device, typically a component of a picture archiving and communication system (PACS), used for the storage and retrieval of digital radiological images and information about the images. Its integral software functions as a database for the storage and management of the radiological images and information contained therein.

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
00866389000167Radlink Laser Pro 16LP1002016-09-21
00866389000112Radlink GPS Tablet 2200TABLET2016-09-21
00866389000136Radlink GPS Bucky CartBucky2016-09-21
00866389000174Radlink SensorSENSOR2016-09-21

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00850059977606TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-07-03
00850059977613TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-07-03
00850059977521TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-06-26
00850059977538TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-06-26
00850059977545TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-06-26
00850059977552TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-06-26
00850059977569TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-06-26
00889024673403NavitrackER®Orthosoft IncLLZ2026-06-26
00889024699762ROSA® ShoulderOrthosoft IncLLZ2026-06-26
00889024699779ROSA® ShoulderOrthosoft IncLLZ2026-06-26
00889024699786ROSA® ShoulderOrthosoft IncLLZ2026-06-26
00889024699793ROSA® ShoulderOrthosoft IncLLZ2026-06-26