510(k) · Cleared
ClearedHyper DLR
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 Aug 4, 2020 as substantially equivalent to K172143 (Shanghai United Imaging Healthcare Co., Ltd., 2018) and 1 other predicate after a 257-day review. Its family tree reaches back 15 generations to 2000.
- Decided
- Aug 4, 2020
- Review
- 257 days
- Class
- Class II
- Product code
- KPS
- Recalls
- None
- Predicates
- 2
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 backK182237 uMI 550 PET/CT SystemShanghai United Imaging Healthcare Co., Ltd. · 2018 · Recalled
- This deviceK193210 Hyper DLRShanghai United Imaging Healthcare Co., Ltd. · 2020
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 backK182237 uMI 550 PET/CT SystemShanghai United Imaging Healthcare Co., Ltd. · 2018 · Recalled
- This deviceK193210 Hyper DLRShanghai United Imaging Healthcare Co., Ltd. · 2020
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 | K182237 | uMI 550 PET/CT System | Shanghai United Imaging Healthcare Co., Ltd. | 2018 | 10 |
| 0 (this device) | 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 |
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? (2)
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 Review Panel: Radiology 4. Identification of Predicate Device(s) Predicate Device 1: 510(k) Number: K172143 Device Name: Emission Computed Tomography System Model(s): uMI 780 Regulatory Information Regulation Number:… | 2018 |
| * | K182237 | uMI 550 PET/CT SystemSummary page 4…me: Emission Computed Tomography System Regulatory Class: II Product Code: KPS, JAK Review Panel: Radiology Predicate Device 2: 510(k) Number: K182237 Device Name: Emission Computed Tomography System Model(s): uMI 550 Page… | 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)
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 3 companies; a new generation was cleared every 1.0 years on median.
- 12 of the 21 ancestors have a recall of any class.
- 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. 2020, 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 DLR is an image processing function intended to be used by radiologists and nuclear medicine physicians to reduce noise of the fluorodeoxyglucose (FDG) PET images.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K193210 · printed Nov 6, 2026
Cite this page
510(k) Report. “K193210: Hyper DLR.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K193210
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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