TRAQinform IQ

Primary DI
00860007104909
Brand
TRAQinform IQ
Company
Aiq Global, Inc.
Model
1
Device description
TRAQinform IQ is a software tool used to aid in evaluation and information management of digital medical images by trained medical professionals including, but not limited to, radiologists, oncologists, nuclear medicine physicians, medical imaging technologists, dosimetrists and physicists. The medical modalities of these medical images include DICOM CT and PET as supported by ACR/NEMA DICOM 3.0.TRAQinform IQ assists in the following indications:• Receive, store, retrieve, display and process digital medical images.• Create, display and print reports from those images.• Provide medical professionals with the ability to display, register, and fuse medical images.• Identify Regions of Interest (ROIs) and perform ROI contouring allowing quantitative/statistical analysis of full or partial body scans.• Evaluate quantitative change in ROIs (total or partial body; individual ROI within individual) with 3D interactive rendering of images with highlighted ROIs
Published
2022-09-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
K173444000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K173444000Quantitative Total Extensible Imaging (QTxI)Aiq Solutions, Inc.2018-07-23LLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860007104909PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860007104909008600071049098600071049090860007104909

GMDN Terms#

Term, Definition table
TermDefinition
Radiology information system application softwareAn application software program, routines, and/or algorithms used as or in a radiology information system (RIS) to electronically receive, collect, store, manage, assist in analysis of, display, output, and distribute data, within/between facilites, to support the administrative and clinical activities associated with the provision and utilization of radiology services and facilities. It may be used for patient scheduling and work-list generation for specific radiological systems; it may be used in conjunction with PACS and include various technology imaging modalities. It is installed into a dedicated radiology information system or existing mainframe or decentralized computers/network.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080830489
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860007104916TRAQinform IQ 22.x2024-11-22
00860007104923TRAQinform Preprocessor12022-09-22
00860007104947TRAQinform Reports12022-09-22

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