510(k) · Cleared
ClearedTRAQinform IQ
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aiq Global, Inc. · LLZ System, Image Processing, Radiological
Cleared on Sep 5, 2024 as substantially equivalent to K173444 (Aiq Solutions, Inc., 2018) after a 262-day review. Its family tree reaches back 9 generations to 1995.
- Decided
- Sep 5, 2024
- Review
- 262 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K950279 (1995). 40 ancestors in all, the oldest K913475 (1991). No later device cites it as a predicate yet.
- Root · 9 generations backK950279 TOMTECP90Tomtec Imaging Systems, Inc. · 1995
- 5 generations between
- 3 generations backK111319 Ibis Explorer and Markup SoftwareMedqia · 2011
- 2 generations backK122205 EXINIExini Diagnostics AB · 2012
- 1 generation backK173444 Quantitative Total Extensible Imaging (QTxI)Aiq Solutions, Inc. · 2018
- This deviceK233998 TRAQinform IQAiq Global, Inc. · 2024
Show all 9 generations
- Root · 9 generations backK950279 TOMTECP90Tomtec Imaging Systems, Inc. · 1995
- 8 generations backK964803 Univision Echocardiology SystemNetwork Concepts, Inc. · 1997
- 7 generations backK980060 EcholinkMpacs, LLC · 1998
- 6 generations backK992259 Echocardiography System Series 95000Camtronics, Ltd. · 1999
- 5 generations backK041029 KinetdxSiemens Medi Cal Solutions, Inc. · 2004 · Recalled
- 4 generations backK053133 Syngo Dynamics, Version 5.0Siemens Medical Solutions USA, Inc. · 2005 · Recalled
- 3 generations backK111319 Ibis Explorer and Markup SoftwareMedqia · 2011
- 2 generations backK122205 EXINIExini Diagnostics AB · 2012
- 1 generation backK173444 Quantitative Total Extensible Imaging (QTxI)Aiq Solutions, Inc. · 2018
- This deviceK233998 TRAQinform IQAiq Global, Inc. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K950279 | TOMTECP90 | Tomtec Imaging Systems, Inc. | 1995 | — |
| −8 | K964803 | Univision Echocardiology System | Network Concepts, Inc. | 1997 | — |
| −7 | K980060 | Echolink | Mpacs, LLC | 1998 | — |
| −6 | K992259 | Echocardiography System Series 95000 | Camtronics, Ltd. | 1999 | — |
| −5 | K041029 | Kinetdx | Siemens Medi Cal Solutions, Inc. | 2004 | 1 |
| −4 | K053133 | Syngo Dynamics, Version 5.0 | Siemens Medical Solutions USA, Inc. | 2005 | 2 |
| −3 | K111319 | Ibis Explorer and Markup Software | Medqia | 2011 | — |
| −2 | K122205 | EXINI | Exini Diagnostics AB | 2012 | — |
| −1 | K173444 | Quantitative Total Extensible Imaging (QTxI) | Aiq Solutions, Inc. | 2018 | — |
| 0 (this device) | K233998 | TRAQinform IQ | Aiq Global, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 2 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 6 | 0 |
| 1997 | 3 | 0 |
| 1998 | 3 | 0 |
| 2000 | 2 | 0 |
| 2001 | 2 | 0 |
| 2002 | 3 | 0 |
| 2005 | 3 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LLZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LLZ device
- #1 K230955 syngo Application Softwarescore 21.5 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K173444 | Quantitative Total Extensible Imaging (QTxI)Summary page 7…re Archiving and Communications System Product Code: LLZ Regulatory Class: Class II Classification Panel: Radiology Predicate Device Name of Device: QTxI 510(k) Number: K173444 Regulation No: 21 CFR 892.2050 Product Code: LLZ Regulatory Class: Class II Classification Panel: Radiology Reference Device Nam… | 2018 |
| † | K071964 | Mim 4.1 (Seastar) | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 29 years and passes through 10 companies; a new generation was cleared every 1.5 years on median.
- 8 of the 40 ancestors have a recall of any class.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · LLZ
58in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LLZ
173in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LLZ
11in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LLZ
116in 2025
MAUDE reports naming product code LLZ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 76 | 36 | 20 | 152 |
| 2008 | 94 | 52 | 32 | 154 |
| 2009 | 70 | 62 | 21 | 145 |
| 2010 | 51 | 98 | 17 | 145 |
| 2011 | 106 | 79 | 30 | 454 |
| 2012 | 82 | 87 | 12 | 266 |
| 2013 | 95 | 84 | 64 | 1,130 |
| 2014 | 78 | 89 | 6 | 15,631 |
| 2015 | 64 | 90 | 16 | 211 |
| 2016 | 82 | 90 | 12 | 290 |
| 2017 | 78 | 107 | 5 | 104 |
| 2018 | 104 | 105 | 7 | 72 |
| 2019 | 74 | 107 | 2 | 88 |
| 2020 | 81 | 115 | 6 | 82 |
| 2021 | 83 | 116 | 3 | 70 |
| 2022 | 65 | 137 | 4 | 28 |
| 2023 | 87 | 157 | 8 | 26 |
| 2024 | 62 | 131 | 6 | 42 |
| 2025 | 58 | 173 | 11 | 116 |
| 2026 | 45 | 110 | 14 | — |
What is it indicated for?
TRAQinform IQ is a software only device that provides a quantitative TRAQinform Report on lesions identified as Regions of Interest (ROI) in PET/CT DICOM compliant imaging data acquired, interpreted, and reported on per local practice prior to device use. Clinicians responsible for patient care and for ordering TRAQinform Reports as an adjunct to locally reported image interpretation do not interact directly with the device. Clinicians responsible for…
Read the full statement (468 words)
TRAQinform IQ is a software only device that provides a quantitative TRAQinform Report on lesions identified as Regions of Interest (ROI) in PET/CT DICOM compliant imaging data acquired, interpreted, and reported on per local practice prior to device use.
Clinicians responsible for patient care and for ordering TRAQinform Reports as an adjunct to locally reported image interpretation do not interact directly with the device. Clinicians responsible for local image interpretation do not interact with the device and generate their reporting before and independently of the TRAQinform Report.
The TRAQinform Report is generated by the device manufacturer and signed by a U.S. board certified physician responsible for supervising central report generation and qualified to practice nuclear radiology/medicine. The TRAQinform Report is for use by trained medical professionals including but not limited to oncologists, nuclear radiologists/physicians, medical imaging technologists, dosimetrists, and physicists.
TRAQinform IQ software contains the following functionalities:
• Automated matching of ROI between previously performed CT and PET/CT DICOM 3.0 volumetric medical images.
• In order to perform automated matching of ROI and quantitative analysis of previously performed CT and PET/CT DICOM 3.0 volumetric medical images, the software initially performs the following functions:
▪ Machine learning skeletal and anatomic structure segmentation.
▪ Threshold-based ROI identification and contouring.
• Automated quantitative analysis to assess previously performed CT and PET/CT DICOM 3.0 volumetric medical images, including: change in total volume and density of each identified ROI, and change in Fludeoxyglucose F18 (FDG) tracer uptake of each identified ROI among images.
• Generation of images of the anatomy combined with spatial and quantitative information, including computed classification of quantitative FDG ROI changes.
For multi-timepoint quantitative analysis, recommended use is in adult patients 22 years and older with partial or whole-body PET/CT acquired following administration of FDG per approved drug prescribing information and with the second FDG administration separated from the first by a period not to exceed 12 months.
For single-timepoint quantitative analysis, recommended use is in adult patients 22 years and older with partial or whole-body PET/CT following administration of FDG, a PSMA targeted PET drug, or a SSTR-targeted PET drug per approved drug prescribing information.
Discrepancies between TRAQinform IQ and local PET/CT reporting have been investigated and use of TRAQinform IQ has not been established for binary patient level progression or non-progression decisions without multidisciplinary review. Discrepancies between TRAQinform IQ and local PET/CT reporting that could impact patient care should therefore prompt consultation with subject matter experts (for example, in tumor board), with a patient-centered focus on discrepant imaging regions and with blinded or otherwise neutral adjudication regarding interpretation/classification source.
TRAQinform IQ is not intended to diagnose any disease, replace the diagnostic procedures for interpretation of CT or PET/CT images, recommend any specific treatment, nor is it intended to replace the skill and judgment of a qualified medical professional.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K233998 · printed Nov 6, 2026
Cite this page
510(k) Report. “K233998: TRAQinform IQ.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K233998
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026