510(k) · Cleared
Recalled · Class II · 2026uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S)
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 Jul 17, 2025 as substantially equivalent to K243538 (Shanghai United Imaging Healthcare Co., Ltd., 2024) after a 31-day review. Its family tree reaches back 16 generations to 2000. 3 later devices descend from it. It has been recalled 2 times.
- Decided
- Jul 17, 2025
- Review
- 31 days
- Class
- Class II
- Product code
- KPS
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 16 generations to K002715 (2000). 22 ancestors in all, the oldest K843696 (1985). 3 later devices descend from it, 2 citing it directly.
- Root · 16 generations backK002715 Ecat Pet ScannerCti Pet Systems, Inc. · 2000 · Recalled
- 12 generations between
- 3 generations backK172143 uMI 780 PET/CT SystemShanghai United Imaging Healthcare Co., Ltd. · 2018 · Recalled
- 2 generations backK241596 uMI PanvivoShanghai United Imaging Healthcare Co., Ltd. · 2024 · Recalled
- 1 generation backK243538 uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S)Shanghai United Imaging Healthcare Co., Ltd. · 2024 · Recalled
- This deviceK251839 uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S)Shanghai United Imaging Healthcare Co., Ltd. · 2025
- Descendant · cites it directly · 1 of its ownK253564 uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo…Shanghai United Imaging Healthcare Co., Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK261427 uMI Panvivo (uMI Panvivo M)Shanghai United Imaging Healthcare Co., Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK260524 uMI Panvivo (uMI Panvivo LS); uMI Panvivo (uMI Panvivo); uMI Panvivo…Shanghai United Imaging Healthcare Co., Ltd. · 2026
Show all 16 generations
- Root · 16 generations backK002715 Ecat Pet ScannerCti Pet Systems, Inc. · 2000 · Recalled
- 15 generations backK013504 Modification to: Ecat Lso Pet/CT ScannerCti Pet Systems, Inc. · 2001 · Recalled
- 14 generations backK023518 Ecat Lso Pet/CT 16Cti Pet Systems, Inc. · 2002 · Recalled
- 13 generations backK033431 Lso Pet/CT Hirez and Lso Pet/CT 16 HirezCti Pet Systems, Inc. · 2003 · Recalled
- 12 generations backK042467 Lso Pet/CT Hirez 64Cti Pet Systems, Inc. · 2004 · Recalled
- 11 generations backK050509 Lso Pet/CT Hirez Series, Models 2I, 6I, 16I, 64ICti Pet Systems, Inc. · 2005
- 10 generations backK060060 Biograph 6Siemens Medical Solutions USA, Inc. · 2006
- 9 generations backK060631 Biograph 64 and Biograph 40Siemens Medical Solutions USA, Inc. · 2006 · Recalled
- 8 generations backK081453 Biograph HD FamilySiemens Medical Solutions USA, Inc. · 2008
- 7 generations backK101550 Biograph MCT FamilySiemens Medical Solutions USA, Inc. · 2010
- 6 generations backK113448 Biograph MCT FamilySiemens Medical Solutions USA, Inc. · 2011
- 5 generations backK123737 Biograph MCT FamilySiemens Medical Solutions USA, Inc. · 2013 · Recalled
- 4 generations backK151486 Biograph mCT and mCT Flow PET/CT ScannersSiemens Medical Solutions USA, Inc. · 2015 · Recalled
- 3 generations backK172143 uMI 780 PET/CT SystemShanghai United Imaging Healthcare Co., Ltd. · 2018 · Recalled
- 2 generations backK241596 uMI PanvivoShanghai United Imaging Healthcare Co., Ltd. · 2024 · Recalled
- 1 generation backK243538 uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S)Shanghai United Imaging Healthcare Co., Ltd. · 2024 · Recalled
- This deviceK251839 uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S)Shanghai United Imaging Healthcare Co., Ltd. · 2025
Most influential descendants
Showing 3 of 3 · See all- K253564uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX)…Shanghai United Imaging Healthcare Co., Ltd. · 2026 · cites it directly1descendant
- K261427uMI Panvivo (uMI Panvivo M)Shanghai United Imaging Healthcare Co., Ltd. · 2026 · cites it directly0descendants
- K260524uMI Panvivo (uMI Panvivo LS); uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S)…Shanghai United Imaging Healthcare Co., Ltd. · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K002715 | Ecat Pet Scanner | Cti Pet Systems, Inc. | 2000 | 2 |
| −15 | K013504 | Modification to: Ecat Lso Pet/CT Scanner | Cti Pet Systems, Inc. | 2001 | 2 |
| −14 | K023518 | Ecat Lso Pet/CT 16 | Cti Pet Systems, Inc. | 2002 | 1 |
| −13 | K033431 | Lso Pet/CT Hirez and Lso Pet/CT 16 Hirez | Cti Pet Systems, Inc. | 2003 | 1 |
| −12 | K042467 | Lso Pet/CT Hirez 64 | Cti Pet Systems, Inc. | 2004 | 1 |
| −11 | K050509 | Lso Pet/CT Hirez Series, Models 2I, 6I, 16I, 64I | Cti Pet Systems, Inc. | 2005 | — |
| −10 | K060060 | Biograph 6 | Siemens Medical Solutions USA, Inc. | 2006 | — |
| −9 | K060631 | Biograph 64 and Biograph 40 | Siemens Medical Solutions USA, Inc. | 2006 | 3 |
| −8 | K081453 | Biograph HD Family | Siemens Medical Solutions USA, Inc. | 2008 | — |
| −7 | K101550 | Biograph MCT Family | Siemens Medical Solutions USA, Inc. | 2010 | — |
| −6 | K113448 | Biograph MCT Family | Siemens Medical Solutions USA, Inc. | 2011 | — |
| −5 | K123737 | Biograph MCT Family | Siemens Medical Solutions USA, Inc. | 2013 | 17 |
| −4 | K151486 | Biograph mCT and mCT Flow PET/CT Scanners | Siemens Medical Solutions USA, Inc. | 2015 | 11 |
| −3 | K172143 | uMI 780 PET/CT System | Shanghai United Imaging Healthcare Co., Ltd. | 2018 | 2 |
| −2 | K241596 | uMI Panvivo | Shanghai United Imaging Healthcare Co., Ltd. | 2024 | 1 |
| −1 | K243538 | uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S) | Shanghai United Imaging Healthcare Co., Ltd. | 2024 | 1 |
| 0 (this device) | K251839 | uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S) | Shanghai United Imaging Healthcare Co., Ltd. | 2025 | — |
| +1 | K253564 | uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI… | Shanghai United Imaging Healthcare Co., Ltd. | 2026 | — |
| +1 | K261427 | uMI Panvivo (uMI Panvivo M) | Shanghai United Imaging Healthcare Co., Ltd. | 2026 | — |
| +2 | K260524 | uMI Panvivo (uMI Panvivo LS); uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI… | Shanghai United Imaging Healthcare Co., Ltd. | 2026 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 3 | 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 |
|---|---|---|---|
| * | K243538 | uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S)Summary page 5…latory Class: II Product Code: KPS, JAK Review Panel: Radiology 4. Identification of Primary/Reference Device(s) Predicate Device 510(k) Number: K243538 Device Name: uMI Panvivo Regulation Name: Emission Computed Tomography System Regulatory Class: II Product Co… | 2024 |
| † | K232712 | uMI Panorama | 2023 |
| † | K193210 | Hyper DLR | 2020 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 11, 2026 | Class II | Z-3286-2026 | Software design | Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are merged into a single study, that prevents patient images from being visible on… |
| Aug 11, 2026 | Class II | Z-3287-2026 | Software design | Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are merged into a single study, that prevents patient images from being visible on… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 25 years and passes through 3 companies; a new generation was cleared every 1.0 years on median.
- 13 of the 22 ancestors have a recall of any class.
- Of its descendants, K253564 (Shanghai United Imaging Healthcare Co., Ltd., 2026) has gone furthest, with 1 descendant of its own.
How does its category compare?
All KPS devicesKPS System, Tomography, Computed, Emission: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 uMI Panvivo is a PET/CT system designed for providing anatomical and functional images. The PET provides the distribution of specific radiopharmaceuticals. CT provides diagnostic tomographic anatomical information as well as photon attenuation information for the scanned region. PET and CT scans can be performed separately. The system is intended for assessing metabolic (molecular) and physiologic functions in various parts of the body. When used…
Read the full statement (248 words)
The uMI Panvivo is a PET/CT system designed for providing anatomical and functional images. The PET provides the distribution of specific radiopharmaceuticals. CT provides diagnostic tomographic anatomical information as well as photon attenuation information for the scanned region. PET and CT scans can be performed separately. The system is intended for assessing metabolic (molecular) and physiologic functions in various parts of the body. When used with radiopharmaceuticals approved by the regulatory authority in the country of use, the uMI Panvivo system generates images depicting the distribution of these radiopharmaceuticals. The images produced by the uMI Panvivo are intended for analysis and interpretation by qualified medical professionals. They can serve as an aid in detection, localization, evaluation, diagnosis, staging, re-staging, monitoring, and/or follow-up of abnormalities, lesions, tumors, inflammation, infection, organ function, disorders, and/or diseases, in several clinical areas such as oncology, cardiology, neurology, infection and inflammation. The images produced by the system can also be used by the physician to aid in radiotherapy treatment planning and interventional radiology procedures.
The 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/K251839 · printed Nov 5, 2026
Cite this page
510(k) Report. “K251839: uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K251839
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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