510(k) · Cleared
ClearedHYPER Focus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shanghai United Imaging Healthcare Co., Ltd. · KPS System, Tomography, Computed, Emission
Cleared on Apr 9, 2021 as substantially equivalent to K113408 (Ge Medical Systems, LLC, 2012) after a 57-day review. Its family tree reaches back 7 generations to 2001.
- Decided
- Apr 9, 2021
- Review
- 57 days
- Class
- Class II
- Product code
- KPS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K010641 (2001). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK010641 GE CT-Pet SystemGe Medical Systems, Inc. · 2001
- 6 generations backK023988 GE Discovery LS SystemGE Medical Systems · 2003 · Recalled
- 5 generations backK040172 Modification to GE Discovery LS SystemGE Medical Systems · 2004 · Recalled
- 4 generations backK041543 GE Discovery STGE Healthcare · 2004 · Recalled
- 3 generations backK050559 GE Discovery VCT SystemGE Medical Systems · 2005 · Recalled
- 2 generations backK081496 Optima Pet/CT 560Ge Medical Systems, LLC · 2008 · Recalled
- 1 generation backK113408 Q. Freeze (Motion VUE2)Ge Medical Systems, LLC · 2012
- This deviceK210418 HYPER FocusShanghai United Imaging Healthcare Co., Ltd. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K010641 | GE CT-Pet System | Ge Medical Systems, Inc. | 2001 | — |
| −6 | K023988 | GE Discovery LS System | GE Medical Systems | 2003 | 1 |
| −5 | K040172 | Modification to GE Discovery LS System | GE Medical Systems | 2004 | 5 |
| −4 | K041543 | GE Discovery ST | GE Healthcare | 2004 | 1 |
| −3 | K050559 | GE Discovery VCT System | GE Medical Systems | 2005 | 1 |
| −2 | K081496 | Optima Pet/CT 560 | Ge Medical Systems, LLC | 2008 | 7 |
| −1 | K113408 | Q. Freeze (Motion VUE2) | Ge Medical Systems, LLC | 2012 | — |
| 0 (this device) | 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 |
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 18.7 · 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 |
|---|---|---|---|
| * | K113408 | Q. Freeze (Motion VUE2)Summary page 6…Comment Q.freeze Software (K113408) HYPER Focus Product Code KPS… | 2012 |
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 20 years and passes through 5 companies; a new generation was cleared every 1.9 years on median.
- 6 of the 9 ancestors have a recall of any class.
How does its category compare?
All KPS devicesKPS System, Tomography, Computed, Emission: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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?
HYPER Focus can be used to correct respiratory motion in PET images. Relative to non-corrected images, HYPER Focus can reduce respiratory motion effects and thus improve the measurement accuracy of SUV and lesion volume.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K210418 · printed Nov 4, 2026
Cite this page
510(k) Report. “K210418: HYPER Focus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K210418
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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