FDA.reportPublic FDA data

UpLinq

Primary DI
00862894000319
Brand
UpLinq
Company
ULTRALINQ HEALTHCARE SOLUTIONS, INC.
Model
UP_001
Device description
Client site located software application that receives IAD-generated data and provides the mechanism by which patient information is transferred to the Application Server (UltraLinq) via internet.
Published
2021-06-02
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LLZSystem, Image Processing, Radiological

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K143176000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K143176000UltraLinqUltralinq Healthcare Solutions, Inc.2015-07-17LLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00862894000319PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00862894000319008628940003198628940003190862894000319

GMDN Terms#

Term, Definition table
TermDefinition
Multidisciplinary medical image management softwareA software application intended to be used to receive, collect, store, and display a broad range of medical imaging/video data, and to distribute the data within or between healthcare facilities to facilitate data analysis, organization, reporting, and sharing (e.g., teaching); it may be designed to allow real-time communication of diagnostic/surgical images and may also enable the control of light settings of a device (e.g., microscope) for image acquisition.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-227-2956support@ultralinq.com

Regulatory Flags#

DUNS number
830536756
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00862894000302UltraLinq58.132016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00850059977538TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-06-26
00850059977545TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-06-26
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00860012615308Denti.AI Auto-ChartDenti.AI Technology IncLLZ2026-06-24
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00850631008872Roentgen WorksBrit Systems, LLCLLZ2026-06-23
00628184004500Intellijoint VIEWIntellijoint Surgical IncLLZ2026-06-09
00860005144082Brain AgeDeephealth, Inc.LLZ2026-06-08
07649997938038Swissmeda Dental Planning SystemSwissmeda AGLLZ2026-06-08
07649997938052Swissmeda Dental Planning SystemSwissmeda AGLLZ2026-06-08
00850025268417Vitrea Advanced VisualizationCanon Medical Informatics, Inc.LLZ2026-06-05
00850631008865Roentgen WorksBrit Systems, LLCLLZ2026-06-05