510(k) · Cleared
Recalled · Class II · 2026uMI 550 PET/CT System
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 Oct 12, 2018 as substantially equivalent to K172143 (Shanghai United Imaging Healthcare Co., Ltd., 2018) after a 56-day review. Its family tree reaches back 14 generations to 2000. 3 later devices descend from it. It has been recalled 10 times.
- Decided
- Oct 12, 2018
- Review
- 56 days
- Class
- Class II
- Product code
- KPS
- Recalls
- 10
- Predicates
- 1
Its longest line of descent runs back 14 generations to K002715 (2000). 20 ancestors in all, the oldest K843696 (1985). 3 later devices descend from it, 2 citing it directly.
- Root · 14 generations backK002715 Ecat Pet ScannerCti Pet Systems, Inc. · 2000 · Recalled
- 10 generations between
- 3 generations backK123737 Biograph MCT FamilySiemens Medical Solutions USA, Inc. · 2013 · Recalled
- 2 generations backK151486 Biograph mCT and mCT Flow PET/CT ScannersSiemens Medical Solutions USA, Inc. · 2015 · Recalled
- 1 generation backK172143 uMI 780 PET/CT SystemShanghai United Imaging Healthcare Co., Ltd. · 2018 · Recalled
- This deviceK182237 uMI 550 PET/CT SystemShanghai United Imaging Healthcare Co., Ltd. · 2018
- Descendant · cites it directly · 1 of its ownK193241 Emission Computed Tomography SystemShanghai United Imaging Healthcare Co., Ltd. · 2020 · Recalled
- Descendant · 2 generations on · 0 of its ownK210001 HYPER AiRShanghai United Imaging Healthcare Co., Ltd. · 2021
- Descendant · cites it directly · 0 of its ownK193210 Hyper DLRShanghai United Imaging Healthcare Co., Ltd. · 2020
Show all 14 generations
- Root · 14 generations backK002715 Ecat Pet ScannerCti Pet Systems, Inc. · 2000 · Recalled
- 13 generations backK013504 Modification to: Ecat Lso Pet/CT ScannerCti Pet Systems, Inc. · 2001 · Recalled
- 12 generations backK023518 Ecat Lso Pet/CT 16Cti Pet Systems, Inc. · 2002 · Recalled
- 11 generations backK033431 Lso Pet/CT Hirez and Lso Pet/CT 16 HirezCti Pet Systems, Inc. · 2003 · Recalled
- 10 generations backK042467 Lso Pet/CT Hirez 64Cti Pet Systems, Inc. · 2004 · Recalled
- 9 generations backK050509 Lso Pet/CT Hirez Series, Models 2I, 6I, 16I, 64ICti Pet Systems, Inc. · 2005
- 8 generations backK060060 Biograph 6Siemens Medical Solutions USA, Inc. · 2006
- 7 generations backK060631 Biograph 64 and Biograph 40Siemens Medical Solutions USA, Inc. · 2006 · Recalled
- 6 generations backK081453 Biograph HD FamilySiemens Medical Solutions USA, Inc. · 2008
- 5 generations backK101550 Biograph MCT FamilySiemens Medical Solutions USA, Inc. · 2010
- 4 generations backK113448 Biograph MCT FamilySiemens Medical Solutions USA, Inc. · 2011
- 3 generations backK123737 Biograph MCT FamilySiemens Medical Solutions USA, Inc. · 2013 · Recalled
- 2 generations backK151486 Biograph mCT and mCT Flow PET/CT ScannersSiemens Medical Solutions USA, Inc. · 2015 · Recalled
- 1 generation backK172143 uMI 780 PET/CT SystemShanghai United Imaging Healthcare Co., Ltd. · 2018 · Recalled
- This deviceK182237 uMI 550 PET/CT SystemShanghai United Imaging Healthcare Co., Ltd. · 2018
Most influential descendants
Showing 3 of 3 · See all- K193241Emission Computed Tomography SystemShanghai United Imaging Healthcare Co., Ltd. · 2020 · cites it directly1descendant
- K210001HYPER AiRShanghai United Imaging Healthcare Co., Ltd. · 2021 · 2 generations on0descendants
- K193210Hyper DLRShanghai United Imaging Healthcare Co., Ltd. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K002715 | Ecat Pet Scanner | Cti Pet Systems, Inc. | 2000 | 2 |
| −13 | K013504 | Modification to: Ecat Lso Pet/CT Scanner | Cti Pet Systems, Inc. | 2001 | 2 |
| −12 | K023518 | Ecat Lso Pet/CT 16 | Cti Pet Systems, Inc. | 2002 | 1 |
| −11 | K033431 | Lso Pet/CT Hirez and Lso Pet/CT 16 Hirez | Cti Pet Systems, Inc. | 2003 | 1 |
| −10 | K042467 | Lso Pet/CT Hirez 64 | Cti Pet Systems, Inc. | 2004 | 1 |
| −9 | K050509 | Lso Pet/CT Hirez Series, Models 2I, 6I, 16I, 64I | Cti Pet Systems, Inc. | 2005 | — |
| −8 | K060060 | Biograph 6 | Siemens Medical Solutions USA, Inc. | 2006 | — |
| −7 | K060631 | Biograph 64 and Biograph 40 | Siemens Medical Solutions USA, Inc. | 2006 | 3 |
| −6 | K081453 | Biograph HD Family | Siemens Medical Solutions USA, Inc. | 2008 | — |
| −5 | K101550 | Biograph MCT Family | Siemens Medical Solutions USA, Inc. | 2010 | — |
| −4 | K113448 | Biograph MCT Family | Siemens Medical Solutions USA, Inc. | 2011 | — |
| −3 | K123737 | Biograph MCT Family | Siemens Medical Solutions USA, Inc. | 2013 | 17 |
| −2 | K151486 | Biograph mCT and mCT Flow PET/CT Scanners | Siemens Medical Solutions USA, Inc. | 2015 | 11 |
| −1 | K172143 | uMI 780 PET/CT System | Shanghai United Imaging Healthcare Co., Ltd. | 2018 | 2 |
| 0 (this device) | K182237 | uMI 550 PET/CT System | Shanghai United Imaging Healthcare Co., Ltd. | 2018 | — |
| +1 | K193241 | Emission Computed Tomography System | Shanghai United Imaging Healthcare Co., Ltd. | 2020 | 6 |
| +2 | K210001 | HYPER AiR | Shanghai United Imaging Healthcare Co., Ltd. | 2021 | — |
| +1 | K193210 | Hyper DLR | Shanghai United Imaging Healthcare Co., Ltd. | 2020 | — |
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 |
|---|---|---|
| 2020 | 2 | 0 |
| 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 |
|---|---|---|---|
| * | K172143 | uMI 780 PET/CT SystemSummary page 4…Regulatory Class: II Product Code: KPS, JAK, Review Panel: Radiology 4. Identification of Predicate Device(s) Predicate Device 510(k) Number: K172143 Device Name: uMI 780 Model(s): uMI 780 Regulatory Information Regulation Number: 21 CFR 892.1200 Regula… | 2018 |
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-3283-2026 | 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… |
| Sep 12, 2025 | Class II | Z-0223-2026 | Other | Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement. |
| Mar 1, 2023 | Class II | Z-1353-2023 | Software design | Due to a software issue where the process of patient scanning, the scatter correction may occasionally fail with will potentially cause a failure of the PET image reconstruction and generation of PET images. |
| May 30, 2022 | Class II | Z-0087-2023 | Device Design | The wireless VSM module of a mobile PET/CT system, operating in an environment with strong Wi-Fi signals, may experience ECG signal and respiratory signal loss due to Wi-Fi interference. ECG and respiratory signal loss during acquisition… |
| Aug 2, 2021 | Class II | Z-2594-2021 | Device Design | The EXAM acquisition workflow could occasionally freeze after canceling the PET scan. |
| Aug 2, 2021 | Class II | Z-2593-2021 | Device Design | The EXAM acquisition workflow could occasionally freeze after canceling the PET scan. |
| Aug 5, 2020 | Class II | Z-0448-2021 | Software design | A potential issue of an incorrect CT scan delay timer to be displayed on the gantry Digital Display Panel (DDP) during multi-phase contrast scanning. This could lead the operator to receive unnecessary exposure to radiation. |
| Jul 16, 2020 | Class II | Z-2800-2020 | Device Design | 1) Service function problem may cause false marking of a bad channel resulting in ring artifacts; 2) Potential intermittent scout scanning interruption due to angle signal drift caused by external interference; 3) Metal edge overlap of… |
| Mar 26, 2020 | Class II | Z-2819-2020 | Software design | In affected software version, of Positron emission tomography and computed tomography system, the CT Hounsfield unit curve may not display in real time when using the bolus tracking protocol with the tracker scan function. If this occurs… |
| Aug 26, 2019 | Class II | Z-1708-2020 | Software design | Potential sporadic software bugs in R001.3.0.0.750505 software version may cause an issue with the PET acquisition raw data causing reconstruction problems during PET/CT scanning and could possibly cause rescans of patients with… |
The 5 latest of 10 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 18 years and passes through 3 companies; a new generation was cleared every 1.0 years on median.
- 11 of the 20 ancestors have a recall of any class.
- Of its descendants, K193241 (Shanghai United Imaging Healthcare Co., Ltd., 2020) has gone furthest, with 1 descendant of its own.
- 4 other devices also cite its predicate K172143.
How does its category compare?
All KPS devicesKPS System, Tomography, Computed, Emission: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 550 PET/CT 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 the metabolic and physiological functions. CT provides diagnostic tomographic anatomical information as well as photon attenuation information for the scanned region. The accurate registration…
Read the full statement (119 words)
The uMI 550 PET/CT 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 the 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 and disorders in, but not limit to, oncology, cardiology and neurology.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K182237 · printed Nov 5, 2026
Cite this page
510(k) Report. “K182237: uMI 550 PET/CT System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K182237
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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