510(k) · Cleared
Recalled · Class II · 2025uEXPLORER
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 Jan 18, 2024 as substantially equivalent to K182938 (Shanghai United Imaging Healthcare Co., Ltd., 2018) after a 216-day review. Its family tree reaches back 15 generations to 2000. It has been recalled once.
- Decided
- Jan 18, 2024
- Review
- 216 days
- Class
- Class II
- Product code
- KPS
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 15 generations to K002715 (2000). 21 ancestors in all, the oldest K843696 (1985). No later device cites it as a predicate yet.
- Root · 15 generations backK002715 Ecat Pet ScannerCti Pet Systems, Inc. · 2000 · Recalled
- 11 generations between
- 3 generations backK151486 Biograph mCT and mCT Flow PET/CT ScannersSiemens Medical Solutions USA, Inc. · 2015 · Recalled
- 2 generations backK172143 uMI 780 PET/CT SystemShanghai United Imaging Healthcare Co., Ltd. · 2018 · Recalled
- 1 generation backK182938 Emission Computed Tomography SystemShanghai United Imaging Healthcare Co., Ltd. · 2018 · Recalled
- This deviceK231762 uEXPLORERShanghai United Imaging Healthcare Co., Ltd. · 2024
Show all 15 generations
- Root · 15 generations backK002715 Ecat Pet ScannerCti Pet Systems, Inc. · 2000 · Recalled
- 14 generations backK013504 Modification to: Ecat Lso Pet/CT ScannerCti Pet Systems, Inc. · 2001 · Recalled
- 13 generations backK023518 Ecat Lso Pet/CT 16Cti Pet Systems, Inc. · 2002 · Recalled
- 12 generations backK033431 Lso Pet/CT Hirez and Lso Pet/CT 16 HirezCti Pet Systems, Inc. · 2003 · Recalled
- 11 generations backK042467 Lso Pet/CT Hirez 64Cti Pet Systems, Inc. · 2004 · Recalled
- 10 generations backK050509 Lso Pet/CT Hirez Series, Models 2I, 6I, 16I, 64ICti Pet Systems, Inc. · 2005
- 9 generations backK060060 Biograph 6Siemens Medical Solutions USA, Inc. · 2006
- 8 generations backK060631 Biograph 64 and Biograph 40Siemens Medical Solutions USA, Inc. · 2006 · Recalled
- 7 generations backK081453 Biograph HD FamilySiemens Medical Solutions USA, Inc. · 2008
- 6 generations backK101550 Biograph MCT FamilySiemens Medical Solutions USA, Inc. · 2010
- 5 generations backK113448 Biograph MCT FamilySiemens Medical Solutions USA, Inc. · 2011
- 4 generations backK123737 Biograph MCT FamilySiemens Medical Solutions USA, Inc. · 2013 · Recalled
- 3 generations backK151486 Biograph mCT and mCT Flow PET/CT ScannersSiemens Medical Solutions USA, Inc. · 2015 · Recalled
- 2 generations backK172143 uMI 780 PET/CT SystemShanghai United Imaging Healthcare Co., Ltd. · 2018 · Recalled
- 1 generation backK182938 Emission Computed Tomography SystemShanghai United Imaging Healthcare Co., Ltd. · 2018 · Recalled
- This deviceK231762 uEXPLORERShanghai United Imaging Healthcare Co., Ltd. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K002715 | Ecat Pet Scanner | Cti Pet Systems, Inc. | 2000 | 2 |
| −14 | K013504 | Modification to: Ecat Lso Pet/CT Scanner | Cti Pet Systems, Inc. | 2001 | 2 |
| −13 | K023518 | Ecat Lso Pet/CT 16 | Cti Pet Systems, Inc. | 2002 | 1 |
| −12 | K033431 | Lso Pet/CT Hirez and Lso Pet/CT 16 Hirez | Cti Pet Systems, Inc. | 2003 | 1 |
| −11 | K042467 | Lso Pet/CT Hirez 64 | Cti Pet Systems, Inc. | 2004 | 1 |
| −10 | K050509 | Lso Pet/CT Hirez Series, Models 2I, 6I, 16I, 64I | Cti Pet Systems, Inc. | 2005 | — |
| −9 | K060060 | Biograph 6 | Siemens Medical Solutions USA, Inc. | 2006 | — |
| −8 | K060631 | Biograph 64 and Biograph 40 | Siemens Medical Solutions USA, Inc. | 2006 | 3 |
| −7 | K081453 | Biograph HD Family | Siemens Medical Solutions USA, Inc. | 2008 | — |
| −6 | K101550 | Biograph MCT Family | Siemens Medical Solutions USA, Inc. | 2010 | — |
| −5 | K113448 | Biograph MCT Family | Siemens Medical Solutions USA, Inc. | 2011 | — |
| −4 | K123737 | Biograph MCT Family | Siemens Medical Solutions USA, Inc. | 2013 | 17 |
| −3 | K151486 | Biograph mCT and mCT Flow PET/CT Scanners | Siemens Medical Solutions USA, Inc. | 2015 | 11 |
| −2 | K172143 | uMI 780 PET/CT System | Shanghai United Imaging Healthcare Co., Ltd. | 2018 | 2 |
| −1 | K182938 | Emission Computed Tomography System | Shanghai United Imaging Healthcare Co., Ltd. | 2018 | 1 |
| 0 (this device) | K231762 | uEXPLORER | Shanghai United Imaging Healthcare Co., Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 2 | 0 |
| 1998 | 1 | 0 |
| 2001 | 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? (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 |
|---|---|---|---|
| * | K182938 | Emission Computed Tomography SystemSummary page 4…tory Class: II Product Code: KPS, JAK, Review Panel: Radiology 4. Identification of Primary/ Reference Device(s) Predicate Device 510(k) Number: K182938 Device Name: uEXPLORER Regulatory Information Regulation Number: 21 CFR 892.1200 Regulation Name: Emission Co… | 2018 |
| † | K193241 | Emission Computed Tomography System | 2020 |
| † | K193210 | Hyper DLR | 2020 |
| † | K230162 | uCT 760 with uWS-CT-Dual Energy Analysis, uCT 780 with uWS-CT-Dual Energy Analysis | 2023 |
| † | K172135 | uCT Computed Tomography X-ray System | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 12, 2025 | Class II | Z-0222-2026 | Other | Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 24 years and passes through 3 companies; a new generation was cleared every 1.0 years on median.
- 12 of the 21 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. 2024, 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 uEXPLORER is a diagnostic imaging system that combines two existing imaging modalities PET and CT. The quantitative distribution information of PET radiopharmaceuticals within the patient body measured by PET can assist healthcare providers in assessing metabolic and physiological functions. CT provides diagnostic tomographic anatomical information as well as photon attenuation information for the scanned region. The accurate registration and fusion…
Read the full statement (213 words)
The uEXPLORER is a diagnostic imaging system that combines two existing imaging modalities PET and CT. The quantitative distribution information of PET radiopharmaceuticals within the patient body measured by PET can assist healthcare providers in assessing metabolic and physiological functions. CT provides diagnostic tomographic anatomical information as well as photon attenuation information for the scanned region. The accurate registration and fusion of PET and CT images provides anatomical reference for the findings in the PET images.
This system is intended to be operated by qualified healthcare professionals to assist in the detection, localization, diagnosis, staging, restaging, treatment planning and treatment response evaluation for diseases, inflammation, infection and disorders in, but not limited to oncology, cardiology and neurology. The system maintains independent functionality of the CT device, allowing for single modality CT diagnostic imaging.
This CT system can be used for low dose CT lung cancer screening for the early detection of lung nodules that may represent cancer. The screening must be performed within the established inclusion criteria of programs / protocols that have been approved and published by either a governmental body or professional medical society.*
* Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231762 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231762: uEXPLORER.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231762
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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