Identity
- Trade Name
- TRAQinform IQ FDA UDI
- Generic Name
- Radiology information system application software FDA UDI
- Device Name
- 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 FDA UDI
- Model / Reference
- 1 FDA UDI
- 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 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860007104909 FDA UDI
- 510(k) Number
- K173444 FDA UDI
- FDA Product Code
- LLZ FDA UDI
- GMDN Term
- Radiology information system application software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.2050 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Radiology information system application software
TRAQinform IQ by Aiq Global, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Aiq Global, Inc.
Sources (1)
- FDA UDI 05e15f47-5cf5-420a-b983-092d8f2f56e5 34 fields · synced May 31, 2026