510(k) · Cleared
ClearedQ. Freeze (Motion VUE2)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Medical Systems, LLC · KPS System, Tomography, Computed, Emission
Cleared on Feb 24, 2012 as substantially equivalent to K081496 (Ge Medical Systems, LLC, 2008) after a 98-day review. Its family tree reaches back 6 generations to 2001. 1 later device descends from it.
- Decided
- Feb 24, 2012
- Review
- 98 days
- Class
- Class II
- Product code
- KPS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K010641 (2001). 8 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK010641 GE CT-Pet SystemGe Medical Systems, Inc. · 2001
- 5 generations backK023988 GE Discovery LS SystemGE Medical Systems · 2003 · Recalled
- 4 generations backK040172 Modification to GE Discovery LS SystemGE Medical Systems · 2004 · Recalled
- 3 generations backK041543 GE Discovery STGE Healthcare · 2004 · Recalled
- 2 generations backK050559 GE Discovery VCT SystemGE Medical Systems · 2005 · Recalled
- 1 generation backK081496 Optima Pet/CT 560Ge Medical Systems, LLC · 2008 · Recalled
- This deviceK113408 Q. Freeze (Motion VUE2)Ge Medical Systems, LLC · 2012
- Descendant · cites it directly · 0 of its ownK210418 HYPER FocusShanghai United Imaging Healthcare Co., Ltd. · 2021
Most influential descendants
Showing 1 of 1 · See all- K210418HYPER FocusShanghai United Imaging Healthcare Co., Ltd. · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K010641 | GE CT-Pet System | Ge Medical Systems, Inc. | 2001 | — |
| −5 | K023988 | GE Discovery LS System | GE Medical Systems | 2003 | 1 |
| −4 | K040172 | Modification to GE Discovery LS System | GE Medical Systems | 2004 | 5 |
| −3 | K041543 | GE Discovery ST | GE Healthcare | 2004 | 1 |
| −2 | K050559 | GE Discovery VCT System | GE Medical Systems | 2005 | 1 |
| −1 | K081496 | Optima Pet/CT 560 | Ge Medical Systems, LLC | 2008 | 7 |
| 0 (this device) | K113408 | Q. Freeze (Motion VUE2) | Ge Medical Systems, LLC | 2012 | — |
| +1 | K210418 | HYPER Focus | Shanghai United Imaging Healthcare Co., Ltd. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 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 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? (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 |
|---|---|---|---|
| * | K081496 | Optima Pet/CT 560Summary page 2…Page 2 Identification of Legally Marketed Equivalent Devices Discovery PET/CT 600 and 690 GE Medical Systems LLC K081496 Comparison with Predicate Devices MotionVUE2 (Q.freeze) PET Software issimilar in design, materials, energy sources, and technolo… | 2008 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K210418 | HYPER Focus | 2021 | 0 |
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 11 years and passes through 4 companies; a new generation was cleared every 1.9 years on median.
- 6 of the 8 ancestors have a recall of any class.
- Of its descendants, K210418 (Shanghai United Imaging Healthcare Co., Ltd., 2021) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K081496.
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?
MotionVUE2 (Q.freeze) is a PET/CT, non- invasive image analysis software application* designed to support the viewing and manipulation of medical images from PET and CT imaging modalities. MotionVUE2 (Q.freeze) offers processing tools to optimize workflow of respiratory gated exams for PET, CT and fused images of respiratory gated datasets for simultaneous viewing in multi-planar volumes and cine loops. MotionVUE2 (Q.freeze) allows the users to generate…
Read the full statement (187 words)
MotionVUE2 (Q.freeze) is a PET/CT, non- invasive image analysis software application* designed to support the viewing and manipulation of medical images from PET and CT imaging modalities.
MotionVUE2 (Q.freeze) offers processing tools to optimize workflow of respiratory gated exams for PET, CT and fused images of respiratory gated datasets for simultaneous viewing in multi-planar volumes and cine loops.
MotionVUE2 (Q.freeze) allows the users to generate from their 4D-PET or 4D-PET/CT series a registered 4D-PET series used for quantification of lesions and analysis of functional activity.
With MotionVUE2 (Q.freeze), users will have the possibility to compare static PET/CT, 4D3-PET/CT, and registered 4DPET series including visual comparison, quantification of lesions, and analysis of functional activity.
MotionVUJE2 (Q.freeze) providesregistration performance of up to 2mnu of center of mass motion when motion is no larger than the diameter of the object.
N'otionVUE2 (Q.freeze) provides comparable/equivalent improvement of quantification results (SUV and size) as 4D PET techniques-
MotionVUE2 (Q.freeze) can be used for features with locally concentrated activity within the entire Thorax area- This area includes the organs where PET/CT imaging has the most challenges due to respiatry motion: Lung, Liver, Pancreas.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113408 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113408: Q. Freeze (Motion VUE2).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113408
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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