510(k) · Cleared
CleareduOmnispace.CT
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 May 17, 2024 as substantially equivalent to K183170 (Shanghai United Imaging Healthcare Co., Ltd., 2019) after a 232-day review. Its family tree reaches back 13 generations to 1991. 3 of the 185 devices in its family, counting itself, have a Class I recall. 1 later device descends from it.
- Decided
- May 17, 2024
- Review
- 232 days
- Class
- Class II
- Product code
- QIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 13 generations to K913770 (1991). 183 ancestors in all, the oldest K837107 (1983). 1 later device descends from it, 1 citing it directly. 3 of the 185 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 backK173001 uWS-CTShanghai United Imaging Healthcare Co., Ltd. · 2018
- 1 generation backK183170 uWS-CTShanghai United Imaging Healthcare Co., Ltd. · 2019
- This deviceK233209 uOmnispace.CTShanghai United Imaging Healthcare Co., Ltd. · 2024
- Descendant · cites it directly · 0 of its ownK242624 Medical Image Post-processing Software (uOmnispace.CT)Shanghai United Imaging Healthcare Co., Ltd. · 2025
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 backK173001 uWS-CTShanghai United Imaging Healthcare Co., Ltd. · 2018
- 1 generation backK183170 uWS-CTShanghai United Imaging Healthcare Co., Ltd. · 2019
- This deviceK233209 uOmnispace.CTShanghai United Imaging Healthcare Co., Ltd. · 2024
Class I recalls in this family
Most influential descendants
Showing 1 of 1 · See all- K242624Medical Image Post-processing Software (uOmnispace.CT)Shanghai United Imaging Healthcare Co., Ltd. · 2025 · cites it directly0descendants
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 | K173001 | uWS-CT | Shanghai United Imaging Healthcare Co., Ltd. | 2018 | — |
| −1 | K183170 | uWS-CT | Shanghai United Imaging Healthcare Co., Ltd. | 2019 | — |
| 0 (this device) | K233209 | uOmnispace.CT | Shanghai United Imaging Healthcare Co., Ltd. | 2024 | — |
| +1 | K242624 | Medical Image Post-processing Software (uOmnispace.CT) | Shanghai United Imaging Healthcare Co., Ltd. | 2025 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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.
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 23.5 · 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 |
|---|---|---|---|
| * | K183170 | uWS-CTSummary page 5…Product Code: QIH Regulation Number: 21 CFR 892.2050 Review Panel: Radiology 4. Identification of Predicate Device(s) Predicate Device 510(k) Number: K183170 Common Name: Medical image management and processing system Model: uWS-CT Regulatory Information… | 2019 |
| † | K230162 | uCT 760 with uWS-CT-Dual Energy Analysis, uCT 780 with uWS-CT-Dual Energy Analysis | 2023 |
| † | K230039 | uOmnispace | 2023 |
| † | K170221 | syngo.CT Cardiac Planning | 2017 |
| † | K133643 | Syngo, CT Liver Analysis | 2014 |
| † | K182130 | iSchemaView RAPID | 2018 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K242624 | Medical Image Post-processing Software (uOmnispace.CT) | 2025 | 0 |
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 33 years and passes through 7 companies; a new generation was cleared every 1.5 years on median.
- 43 of the 183 ancestors have a recall of any class; 3 have a Class I recall.
- Of its descendants, K242624 (Shanghai United Imaging Healthcare Co., Ltd., 2025) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K183170.
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. 2024, 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.CT is a software 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.CT Colon Analysis application is intended to provide the user a tool to enable easy visualization and efficient evaluation of CT volume data sets of the colon. -The uOmnispace.CT Dental application is intended…
Read the full statement (445 words)
uOmnispace.CT is a software 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.CT Colon Analysis application is intended to provide the user a tool to enable easy visualization and efficient evaluation of CT volume data sets of the colon.
-The uOmnispace.CT Dental application is intended to provide the user a tool to reconstruct panoramic and paraxial views of jaw.
-The uOmnispace.CT Lung Density Analysis application is intended to segment pulmonary, lobes, and airway, providing the user quantitative parameters, structure information to evaluate the lung and airway.
-The uOmnispace.CT Lung Nodule application is intended to provide the user a tool for the review and analysis of thoracic CT images, providing quantitative and characterizing information about nodules in the lung in a single study, or over the time course of several thoracic studies.
-The uOmnispace.CT Vessel Analysis application is intended to provide a tool for viewing, manipulating, and evaluating CT vascular images.
-The uOmnispace.CT Brain Perfusion application is intended to calculate the parameters such as: CBV, CBF, etc. in order to analyze functional blood flow information about a region of interest (ROI) in brain.
-The uOmnispace.CT Heart application is intended to segment heart and extract coronary artery. It also provides analysis of vascular stenosis, plaque and heart function.
-The uOmnispace.CT Calcium Scoring application is intended to identify calcifications and calculate the calcium score.
-The uOmnispace.CT Dynamic Analysis application is intended to support visualization of the CT datasets over time with the 3D/4D display modes.
-The uOmnispace.CT Bone Structure Analysis application is intended to provide visualization and labels for the ribs and spine, and support batch function for intervertebral disk.
-The uOmnispace.CT Liver Evaluation application is intended to provide processing and visualization for liver segmentation and vessel extraction. It also provides a tool for the user to perform liver separation and residual liver segments evaluation.
-The uOmnispace.CT Dual Energy is a post-processing software package that accepts UIH CT images acquired using different tube voltages and/or tube currents of the same anatomical location. The uOmnispace.CT Dual Energy application is intended to provide information on the chemical composition of the scanned body materials and/or contrast agents. Additionally, it enables images to be generated at multiple energies within the available spectrum.
-The uOmnispace.CT Cardiovascular Combined Analysis is an image analysis software package for evaluating contrast enhanced CT images. The CT Cardiovascular Combined Analysis is intended to analyze vascular and cardiac structures. It can be used in the qualitative and quantitative for the analysis of head-neck, abdomen, multi-body part combined, TAVR (Transcatheter Aortic Valve Replacement) CT data as input for the planning of cardiovascular procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K233209 · printed Nov 6, 2026
Cite this page
510(k) Report. “K233209: uOmnispace.CT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K233209
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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