510(k) · Cleared
ClearedACQA
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Texas Medical Imaging Consultants · KPS System, Tomography, Computed, Emission
Cleared on Jan 13, 2012 as substantially equivalent to K041543 (GE Healthcare, 2004) and 1 other predicate after an 87-day review. Its family tree reaches back 6 generations to 1995.
- Decided
- Jan 13, 2012
- Review
- 87 days
- Class
- Class II
- Product code
- KPS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K945512 (1995). 13 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK945512 HRSW Option for CT Twin FlashElscint, Inc. · 1995
- 5 generations backK970980 Cardiac Scoring for CT ScannersElscint, Inc. · 1997
- 4 generations backK982004 CT Coronary Artery Calcification Scoring (Cacs) Option for Advantage…General Electric Co. · 1998
- 3 generations backK020929 Smartscore 3.5; Smartscore 4.0; Smartscore 4.5GE Medical Systems · 2002
- 2 generations backK022919 Smart Breath Respiratory Compensation OptionGE Medical Systems · 2002
- 1 generation backK032915 Advantage 4D OptionGe Medical Systems, LLC · 2003
- This deviceK113086 ACQATexas Medical Imaging Consultants · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K945512 | HRSW Option for CT Twin Flash | Elscint, Inc. | 1995 | — |
| −5 | K970980 | Cardiac Scoring for CT Scanners | Elscint, Inc. | 1997 | — |
| −4 | K982004 | CT Coronary Artery Calcification Scoring (Cacs) Option for Advantage Windows | General Electric Co. | 1998 | — |
| −3 | K020929 | Smartscore 3.5; Smartscore 4.0; Smartscore 4.5 | GE Medical Systems | 2002 | — |
| −2 | K022919 | Smart Breath Respiratory Compensation Option | GE Medical Systems | 2002 | — |
| −1 | K032915 | Advantage 4D Option | Ge Medical Systems, LLC | 2003 | — |
| 0 (this device) | K113086 | ACQA | Texas Medical Imaging Consultants | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 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 KPS? 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 KPS device
- #1 K253564 uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI…score 18.6 · 17 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K041543 | GE Discovery STSummary page 1…hysician read the original PET images. F. Comparison of Technical Characteristics to Predicate Device: The ACQA system and its predicates, the GE DST (K041543) and the GE Advantage 40-option (K032915) utilize the same type of data sets for analysis and data processing. The ACQA,… | 2004 |
| * | K032915 | Advantage 4D OptionSummary page 1…F. Comparison of Technical Characteristics to Predicate Device: The ACQA system and its predicates, the GE DST (K041543) and the GE Advantage 40-option (K032915) utilize the same type of data sets for analysis and data processing. The ACQA, applicable to all GE PET/CT scanners, acco… | 2003 |
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 17 years and passes through 5 companies; a new generation was cleared every 2.2 years on median.
- 5 of the 13 ancestors have a recall of any class.
- 2 other devices also cite its predicate K041543.
How does its category compare?
All KPS devicesKPS System, Tomography, Computed, Emission: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · KPS
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KPS
65in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KPS
16in 2025
Class I (17 since 2007) Class II/III not classified
Adverse event reports per year · KPS
36in 2025
MAUDE reports naming product code KPS, 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 | 8 | 38 | 22 | 38 |
| 2008 | 17 | 25 | 16 | 11 |
| 2009 | 9 | 42 | 14 | 15 |
| 2010 | 3 | 91 | 4 | 44 |
| 2011 | 7 | 28 | 34 | 56 |
| 2012 | 6 | 94 | 13 | 34 |
| 2013 | 11 | 84 | 13 | 240 |
| 2014 | 11 | 92 | 18 | 33 |
| 2015 | 3 | 112 | 5 | 24 |
| 2016 | 11 | 65 | 16 | 10 |
| 2017 | 11 | 104 | 11 | 31 |
| 2018 | 13 | 59 | 12 (3) | 26 |
| 2019 | 3 | 60 | 5 (5) | 105 |
| 2020 | 12 | 72 | 8 | 22 |
| 2021 | 15 | 66 | 4 | 10 |
| 2022 | 5 | 60 | 8 (6) | 15 |
| 2023 | 12 | 63 | 6 (3) | 22 |
| 2024 | 11 | 59 | 15 | 23 |
| 2025 | 12 | 65 | 16 | 36 |
| 2026 | 6 | 67 | 6 | — |
What is it indicated for?
The ACQA system is a software on GE Advantage Windows workstation computers that allow the user to create averaged CT images for attenuation correction of the whole body or myocardial perfusion PET images, and to register CT images with myocardial perfusion PET images, and save registered CT images for attenuation correction of myocardial perfusion PET images. The PET images corrected with the CT images of ACQA are not a replacement of the original PET images, and they serve as a secondary data set to assist the physicians read the original PET images.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113086 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113086: ACQA.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113086
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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