TRAQinform IQ

GUDID 00860007104909

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

Aiq Global, Inc.

Radiology information system application software

• Primary Device ID: 00860007104909
• NIH Device Record Key: 05e15f47-5cf5-420a-b983-092d8f2f56e5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TRAQinform IQ
• Version Model Number: 1
• Company DUNS: 080830489
• Company Name: Aiq Global, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860007104909 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173444

FDA Product Code

• LLZ: System, Image Processing, Radiological

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-09-30
• Device Publish Date: 2022-09-22

Devices Manufactured by Aiq Global, Inc.

• 00860007104916 - TRAQinform IQ 2: 2024-12-02
• 00860007104909 - TRAQinform IQ: 2022-09-30TRAQinform 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
• 00860007104909 - TRAQinform IQ: 2022-09-30 TRAQinform IQ is a software tool used to aid in evaluation and information management of digital medical images by trained medic
• 00860007104923 - TRAQinform Preprocessor: 2022-09-30 The TRAQinform Preprocessor is a 100% software medical device data system that provides users with the means to filter, perform
• 00860007104947 - TRAQinform Reports: 2022-09-30 TRAQinform Reports is a 100% software medical device data system that provides users with the means to select, render and modify