510(k) · Cleared
CleareduOmnispace.MR
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shanghai United Imaging Healthcare Co., Ltd. · QIH Automated Radiological Image Processing Software
Cleared on Apr 22, 2026 as substantially equivalent to K233186 (Shanghai United Imaging Healthcare Co., Ltd., 2024) after a 211-day review. Its family tree reaches back 15 generations to 1991. 3 of the 186 devices in its family, counting itself, have a Class I recall.
- Decided
- Apr 22, 2026
- Review
- 211 days
- Class
- Class II
- Product code
- QIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 15 generations to K913770 (1991). 185 ancestors in all, the oldest K837107 (1983). No later device cites it as a predicate yet. 3 of the 186 devices in this family, counting this one, have a Class I recall.
- Root · 15 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 11 generations between
- 3 generations backK183164 uWS-MRShanghai United Imaging Healthcare Co., Ltd. · 2019
- 2 generations backK192601 uWS-MRShanghai United Imaging Healthcare Co., Ltd. · 2020
- 1 generation backK233186 uOmnispace.MRShanghai United Imaging Healthcare Co., Ltd. · 2024
- This deviceK253077 uOmnispace.MRShanghai United Imaging Healthcare Co., Ltd. · 2026
Show all 15 generations
- Root · 15 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 14 generations backK963345 Advantage Windows Tissue Volume OptionGE Medical Systems · 1996
- 13 generations backK013381 Advanced Lung Analysis-1General Electric Co. · 2001
- 12 generations backK022013 Lungcare CT Software PackageSiemens Medical Solutions USA, Inc. · 2002
- 11 generations backK033374 Lungcare CT Software Package with Extended FunctionalitySiemens AG Medical Solutions · 2003
- 10 generations backK041484 UndecidedSiemens Medical Solutions USA, Inc. · 2004
- 9 generations backK053301 Cedara I-Response Cedara Pet/CTCedara Software Corp. · 2006
- 8 generations backK071950 Syngo TruedSiemens Medical Solutions USA, Inc. · 2007
- 7 generations backK091373 Syngo TruedSiemens Medical Solutions USA, Inc. · 2009
- 6 generations backK101749 Syngo Trued SoftwareSiemens Medical Solutions · 2010
- 5 generations backK123920 Syngo.ViaSiemens AG Medical Solutions · 2013
- 4 generations backK172999 uWS-MRShanghai United Imaging Healthcare Co., Ltd. · 2018
- 3 generations backK183164 uWS-MRShanghai United Imaging Healthcare Co., Ltd. · 2019
- 2 generations backK192601 uWS-MRShanghai United Imaging Healthcare Co., Ltd. · 2020
- 1 generation backK233186 uOmnispace.MRShanghai United Imaging Healthcare Co., Ltd. · 2024
- This deviceK253077 uOmnispace.MRShanghai United Imaging Healthcare Co., Ltd. · 2026
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −14 | K963345 | Advantage Windows Tissue Volume Option | GE Medical Systems | 1996 | — |
| −13 | K013381 | Advanced Lung Analysis-1 | General Electric Co. | 2001 | — |
| −12 | K022013 | Lungcare CT Software Package | Siemens Medical Solutions USA, Inc. | 2002 | — |
| −11 | K033374 | Lungcare CT Software Package with Extended Functionality | Siemens AG Medical Solutions | 2003 | — |
| −10 | K041484 | Undecided | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −9 | K053301 | Cedara I-Response Cedara Pet/CT | Cedara Software Corp. | 2006 | — |
| −8 | K071950 | Syngo Trued | Siemens Medical Solutions USA, Inc. | 2007 | — |
| −7 | K091373 | Syngo Trued | Siemens Medical Solutions USA, Inc. | 2009 | — |
| −6 | K101749 | Syngo Trued Software | Siemens Medical Solutions | 2010 | — |
| −5 | K123920 | Syngo.Via | Siemens AG Medical Solutions | 2013 | — |
| −4 | K172999 | uWS-MR | Shanghai United Imaging Healthcare Co., Ltd. | 2018 | — |
| −3 | K183164 | uWS-MR | Shanghai United Imaging Healthcare Co., Ltd. | 2019 | — |
| −2 | K192601 | uWS-MR | Shanghai United Imaging Healthcare Co., Ltd. | 2020 | — |
| −1 | K233186 | uOmnispace.MR | Shanghai United Imaging Healthcare Co., Ltd. | 2024 | — |
| 0 (this device) | K253077 | uOmnispace.MR | Shanghai United Imaging Healthcare Co., Ltd. | 2026 | — |
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 QIH device
- #1 K213998 cvi42 Auto Imaging Software Applicationscore 23.6 · 7 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 |
|---|---|---|---|
| * | K233186 | uOmnispace.MRSummary page 6…Product Code: QIH Regulation Number: 21 CFR 892.2050 Review Panel: Radiology 4. Identification of Predicate Device(s) Predicate Device 510(k) Number: K233186 Device Name: uOmnispace.MR Reference Device 1 510(k) Number: K213583… | 2024 |
| † | K213583 | Achieva, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR Systems | 2022 |
| † | K213165 | Rapid | 2022 |
| † | K173467 | Advanced Diffusion Analysis (ADA) application | 2017 |
| † | K243122 | uMR Omega | 2025 |
| † | K193200 | uMR Omega | 2020 |
| † | K220332 | uMR Omega with uWS-MR-MRS | 2022 |
| † | K211059 | CereFlow™ V1.2 | 2023 |
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 · 6 generations back · ◆ in the 2012 ancestors bar of FIG. 12 Class I recalls
- K101347Magnetom Aera; Magnetom SkyraSiemens Medical Solutions USA, Inc. · 2010 · 8 generations back · ◆ in the 2010 ancestors bar of FIG. 12 Class I recalls
- K072237Magnetom VerioSiemens Medical Solutions USA, Inc. · 2007 · 8 generations back · ◆ in the 2007 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 35 years and passes through 7 companies; a new generation was cleared every 1.5 years on median.
- 43 of the 185 ancestors have a recall of any class; 3 have a Class I recall.
How does its category compare?
All QIH devicesQIH Automated Radiological Image Processing Software: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · QIH
94in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QIH
150in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QIH
1so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · QIH
4in 2025
MAUDE reports naming product code QIH, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 11 | 145 | 0 | 0 |
| 2021 | 19 | 125 | 0 | 0 |
| 2022 | 25 | 134 | 0 | 0 |
| 2023 | 45 | 151 | 0 | 0 |
| 2024 | 64 | 141 | 0 | 2 |
| 2025 | 94 | 150 | 0 | 4 |
| 2026 | 78 | 130 | 1 | — |
What is it indicated for?
uOmnispace.MR is a software solution intended to be used for viewing, manipulating, evaluating and analyzing medical images. It supports interpretation and evaluation of examinations within healthcare institutions. It has the following additional indications: The uOmnispace.MR Stitching is intended to create full-format images from overlapping MR volume data sets acquired at multiple stages. The uOmnispace.MR Dynamic application is intended to provide a…
Read the full statement (362 words)
uOmnispace.MR is a software solution intended to be used for viewing, manipulating, evaluating and analyzing medical images. It supports interpretation and evaluation of examinations within healthcare institutions. It has the following additional indications:
The uOmnispace.MR Stitching is intended to create full-format images from overlapping MR volume data sets acquired at multiple stages.
The uOmnispace.MR Dynamic application is intended to provide a general post-processing tool for time course studies.
The uOmnispace.MR MRS (MR Spectroscopy) is intended to evaluate the molecule constitution and spatial distribution of cell metabolism. It provides a set of tools to view, process, and analyze the complex MRS data. This application supports the analysis for both SVS (Single Voxel Spectroscopy) and CSI (Chemical Shift Imaging) data.
The uOmnispace.MR MAPs application is intended to provide a number of arithmetic and statistical functions for evaluating dynamic processes and images. These functions are applied to the grayscale values of medical images.
The uOmnispace.MR Breast Evaluation application provides the user a tool to calculate parameter maps from contrast-enhanced time-course images.
The uOmnispace.MR Brain Perfusion application is intended to allow the visualization of temporal variations in the dynamic susceptibility time series of MR datasets.
The uOmnispace.MR Vessel Analysis is intended to provide a tool for viewing, manipulating, and evaluating MR vascular images.
The uOmnispace.MR DCE analysis is intended to view, manipulate, and evaluate dynamic contrast-enhanced MRI images.
The uOmnispace.MR United Neuro is intended to view, manipulate, and evaluate MR neurological images.
The uOmnispace.MR Cardiac Function is intended to view, evaluate functional analysis of cardiac MR images.
The uOmnispace.MR Flow Analysis is intended to view, evaluate flow analysis of flow MR images.
The uOmnispace.MR Cardiac Perfusion is intended to view, process and analyze MR cardiac perfusion images.
The uOmnispace.MR Cardiac Viability is intended to view, process and analyze MR late gadolinium enhancement images.
The uOmnispace.MR Diffusion Analysis is intended to view, process and analyze MR diffusion images.
The uOmnispace.MR SWI+ is intended to view and generate susceptibility weighted images (SWI) and quantitative susceptibility mapping (QSM) images.
The uOmnispace.MR Multiplex Analysis is intended to generate and view multiple virtual contrast images.
The uOmnispace.MR ASL is intended to view, process and analyze MR arterial spin labeling (ASL) images.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253077 · printed Nov 4, 2026
Cite this page
510(k) Report. “K253077: uOmnispace.MR.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K253077
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026