510(k) · Cleared
CleareduOmnispace.MI
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shanghai United Imaging Healthcare Co., Ltd. · LLZ System, Image Processing, Radiological
Cleared on Dec 20, 2023 as substantially equivalent to K192630 (Shanghai United Imaging Healthcare Co., Ltd., 2020) after an 83-day review. Its family tree reaches back 13 generations to 1991. 3 of the 184 devices in its family, counting itself, have a Class I recall.
- Decided
- Dec 20, 2023
- Review
- 83 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 13 generations to K913770 (1991). 183 ancestors in all, the oldest K837107 (1983). No later device cites it as a predicate yet. 3 of the 184 devices in this family, counting this one, have a Class I recall.
- Root · 13 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 9 generations between
- 3 generations backK123920 Syngo.ViaSiemens AG Medical Solutions · 2013
- 2 generations backK172998 uWS-MIShanghai United Imaging Healthcare Co., Ltd. · 2018
- 1 generation backK192630 uWS-MIShanghai United Imaging Healthcare Co., Ltd. · 2020
- This deviceK233176 uOmnispace.MIShanghai United Imaging Healthcare Co., Ltd. · 2023
Show all 13 generations
- Root · 13 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 12 generations backK963345 Advantage Windows Tissue Volume OptionGE Medical Systems · 1996
- 11 generations backK013381 Advanced Lung Analysis-1General Electric Co. · 2001
- 10 generations backK022013 Lungcare CT Software PackageSiemens Medical Solutions USA, Inc. · 2002
- 9 generations backK033374 Lungcare CT Software Package with Extended FunctionalitySiemens AG Medical Solutions · 2003
- 8 generations backK041484 UndecidedSiemens Medical Solutions USA, Inc. · 2004
- 7 generations backK053301 Cedara I-Response Cedara Pet/CTCedara Software Corp. · 2006
- 6 generations backK071950 Syngo TruedSiemens Medical Solutions USA, Inc. · 2007
- 5 generations backK091373 Syngo TruedSiemens Medical Solutions USA, Inc. · 2009
- 4 generations backK101749 Syngo Trued SoftwareSiemens Medical Solutions · 2010
- 3 generations backK123920 Syngo.ViaSiemens AG Medical Solutions · 2013
- 2 generations backK172998 uWS-MIShanghai United Imaging Healthcare Co., Ltd. · 2018
- 1 generation backK192630 uWS-MIShanghai United Imaging Healthcare Co., Ltd. · 2020
- This deviceK233176 uOmnispace.MIShanghai United Imaging Healthcare Co., Ltd. · 2023
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −12 | K963345 | Advantage Windows Tissue Volume Option | GE Medical Systems | 1996 | — |
| −11 | K013381 | Advanced Lung Analysis-1 | General Electric Co. | 2001 | — |
| −10 | K022013 | Lungcare CT Software Package | Siemens Medical Solutions USA, Inc. | 2002 | — |
| −9 | K033374 | Lungcare CT Software Package with Extended Functionality | Siemens AG Medical Solutions | 2003 | — |
| −8 | K041484 | Undecided | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −7 | K053301 | Cedara I-Response Cedara Pet/CT | Cedara Software Corp. | 2006 | — |
| −6 | K071950 | Syngo Trued | Siemens Medical Solutions USA, Inc. | 2007 | — |
| −5 | K091373 | Syngo Trued | Siemens Medical Solutions USA, Inc. | 2009 | — |
| −4 | K101749 | Syngo Trued Software | Siemens Medical Solutions | 2010 | — |
| −3 | K123920 | Syngo.Via | Siemens AG Medical Solutions | 2013 | — |
| −2 | K172998 | uWS-MI | Shanghai United Imaging Healthcare Co., Ltd. | 2018 | — |
| −1 | K192630 | uWS-MI | Shanghai United Imaging Healthcare Co., Ltd. | 2020 | — |
| 0 (this device) | K233176 | uOmnispace.MI | Shanghai United Imaging Healthcare Co., Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1987 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 5 | 0 |
| 1992 | 2 | 0 |
| 1993 | 2 | 0 |
| 1994 | 5 | 0 |
| 1995 | 5 | 0 |
| 1996 | 8 | 0 |
| 1997 | 9 | 0 |
| 1998 | 12 | 0 |
| 1999 | 6 | 0 |
| 2000 | 11 | 0 |
| 2001 | 17 | 0 |
| 2002 | 13 | 0 |
| 2003 | 8 | 0 |
| 2004 | 15 | 0 |
| 2005 | 11 | 0 |
| 2006 | 10 | 0 |
| 2007 | 8 | 1 |
| 2008 | 4 | 0 |
| 2009 | 4 | 0 |
| 2010 | 2 | 1 |
| 2011 | 4 | 0 |
| 2012 | 3 | 1 |
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.
3 devices in this family have a Class I recall. 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 LLZ device
- #1 K230955 syngo Application Softwarescore 21.5 · 11 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 |
|---|---|---|---|
| * | K192630 | uWS-MISummary page 4…Product Code: LLZ Regulation Number: 21 CFR 892.2050 Review Panel: Radiology 4. Identification of Predicate Device(s) Predicate Device 510(k) Number: K192630 Device Name: uWS-MI Reference Device#1 510(k) Number: K173897 Pa… | 2020 |
| † | K173897 | syngo.via MI Workflows | 2018 |
| † | K183170 | uWS-CT | 2019 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (3 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K121434Software Syngo MR D13A for the Magnetom Systems Aera/Skyra/Avanto/VerioSiemens Medi Cal Solutions, Inc. · 2012 · 4 generations back · ◆ in the 2012 ancestors bar of FIG. 12 Class I recalls
- K101347Magnetom Aera; Magnetom SkyraSiemens Medical Solutions USA, Inc. · 2010 · 6 generations back · ◆ in the 2010 ancestors bar of FIG. 12 Class I recalls
- K072237Magnetom VerioSiemens Medical Solutions USA, Inc. · 2007 · 6 generations back · ◆ in the 2007 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 32 years and passes through 7 companies; a new generation was cleared every 1.8 years on median.
- 43 of the 183 ancestors have a recall of any class; 3 have a Class I recall.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · LLZ
58in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LLZ
173in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LLZ
11in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LLZ
116in 2025
MAUDE reports naming product code LLZ, 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 | 76 | 36 | 20 | 152 |
| 2008 | 94 | 52 | 32 | 154 |
| 2009 | 70 | 62 | 21 | 145 |
| 2010 | 51 | 98 | 17 | 145 |
| 2011 | 106 | 79 | 30 | 454 |
| 2012 | 82 | 87 | 12 | 266 |
| 2013 | 95 | 84 | 64 | 1,130 |
| 2014 | 78 | 89 | 6 | 15,631 |
| 2015 | 64 | 90 | 16 | 211 |
| 2016 | 82 | 90 | 12 | 290 |
| 2017 | 78 | 107 | 5 | 104 |
| 2018 | 104 | 105 | 7 | 72 |
| 2019 | 74 | 107 | 2 | 88 |
| 2020 | 81 | 115 | 6 | 82 |
| 2021 | 83 | 116 | 3 | 70 |
| 2022 | 65 | 137 | 4 | 28 |
| 2023 | 87 | 157 | 8 | 26 |
| 2024 | 62 | 131 | 6 | 42 |
| 2025 | 58 | 173 | 11 | 116 |
| 2026 | 45 | 110 | 14 | — |
What is it indicated for?
uOmnispace.MI is a software solution intended to be used for viewing, processing, evaluating and analyzing of PET, CT, MR, SPECT images. It supports interpretation and evaluation of examinations within healthcare institutions. It has the following additional indications: ■ uOmnispace.MI MM Fusion application is intended to provide tools for viewing, analyzing and reporting PET, CT, MR, SPECT data with its flexible workflow and optimized layout protocols…
Read the full statement (224 words)
uOmnispace.MI is a software solution intended to be used for viewing, processing, evaluating and analyzing of PET, CT, MR, SPECT images. It supports interpretation and evaluation of examinations within healthcare institutions. It has the following additional indications:
■ uOmnispace.MI MM Fusion application is intended to provide tools for viewing, analyzing and reporting PET, CT, MR, SPECT data with its flexible workflow and optimized layout protocols for dedicated reporting purposes on oncology, neurology, cardiology.
■ uOmnispace.MI MM Oncology application is intended to provide tools to display and analyze the follow-up PET, CT, MR data, with which users can do image registration, lesion segmentation, and statistical analysis.
■ uOmnispace.MI Dynamic Analysis application is intended to display PET data and anatomical data such as CT or MR, and supports to do lesion segmentation and output associated time activity curve.
■ uOmnispace.MI NeuroQ application is intended to analyze the brain PET scan, give quantitative results of the relative activity of different brain regions, and make comparison of activity of normal brain regions in AC database or between two studies from the same patient, as well as provide analysis of amyloid uptake levels in the brain.
■ uOmnispace.MI Emory Cardiac Toolbox application is intended to provide cardiac short axis reconstruction, browsing function. And it also performs perfusion analysis, activity analysis and cardiac function analysis of the cardiac short axis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K233176 · printed Nov 6, 2026
Cite this page
510(k) Report. “K233176: uOmnispace.MI.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K233176
Report an extraction error
Are you the manufacturer?
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