510(k) · Cleared
CleareduMR Omega with uWS-MR-MRS
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shanghai United Imaging Healthcare Co., Ltd. · LNH System, Nuclear Magnetic Resonance Imaging
Cleared on Oct 27, 2022 as substantially equivalent to K193200 (Shanghai United Imaging Healthcare Co., Ltd., 2020) after a 265-day review. Its family tree reaches back 15 generations to 1997. 4 of the 47 devices in its family, counting itself, have a Class I recall. 7 later devices descend from it.
- Decided
- Oct 27, 2022
- Review
- 265 days
- Class
- Class II
- Product code
- LNH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 15 generations to K971684 (1997). 39 ancestors in all, the oldest K932271 (1994). 7 later devices descend from it, 2 citing it directly. 4 of the 47 devices in this family, counting this one, have a Class I recall.
- Root · 15 generations backK971684 Magnetom Project 047 System (Numaris 3.5 Software)Siemens Medical Solutions USA, Inc. · 1997 · Recalled
- 11 generations between
- 3 generations backK181371 uMR 790Shanghai United Imaging Healthcare Co., Ltd. · 2018
- 2 generations backK191157 uMR 780, uMR 790Shanghai United Imaging Healthcare Co., Ltd. · 2019
- 1 generation backK193200 uMR OmegaShanghai United Imaging Healthcare Co., Ltd. · 2020
- This deviceK220332 uMR Omega with uWS-MR-MRSShanghai United Imaging Healthcare Co., Ltd. · 2022
- Descendant · cites it directly · 6 of its ownK230152 uMR OmegaShanghai United Imaging Healthcare Co., Ltd. · 2023
- Descendant · 2 generations on · 3 of its ownK240540 uMR OmegaShanghai United Imaging Healthcare Co., Ltd. · 2024
- Descendant · cites it directly · 2 of its ownK243122 uMR OmegaShanghai United Imaging Healthcare Co., Ltd. · 2025
- Descendant · 2 generations on · 1 of its ownK243547 uMR UltraShanghai United Imaging Healthcare Co., Ltd. · 2025
- Descendant · 2 generations on · 1 of its ownK233673 uMR JupiterShanghai United Imaging Healthcare Co., Ltd. · 2024
Show all 15 generations
- Root · 15 generations backK971684 Magnetom Project 047 System (Numaris 3.5 Software)Siemens Medical Solutions USA, Inc. · 1997 · Recalled
- 14 generations backK032428 Magnetom Avanto MR SystemSiemens Medical Solutions USA, Inc. · 2003 · Recalled
- 13 generations backK041112 Magnetom Espree SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 12 generations backK052164 Magnetom Systems with Software Syngo MR 2006ASiemens Medical Solutions USA, Inc. · 2005
- 11 generations backK062454 Magnetom Systems - I-Class and T-Class ReleasesSiemens Medi Cal Solutions, Inc. · 2006
- 10 generations backK072237 Magnetom VerioSiemens Medical Solutions USA, Inc. · 2007 · Recalled (Class I)
- 9 generations backK082427 Syngo MR B17Siemens Medical Solutions USA, Inc. · 2008
- 8 generations backK101347 Magnetom Aera; Magnetom SkyraSiemens Medical Solutions USA, Inc. · 2010 · Recalled (Class I)
- 7 generations backK111242 Magnetom Aera and Magnetom SkyraSiemens Medical Solutions USA, Inc. · 2011 · Recalled
- 6 generations backK121434 Software Syngo MR D13A for the Magnetom Systems…Siemens Medi Cal Solutions, Inc. · 2012 · Recalled (Class I)
- 5 generations backK123938 Syngo MR B19 for Magnetom Avanto, Syngo MR B19 for Magnetom Espree…Siemens Medical Solutions USA, Inc. · 2013
- 4 generations backK132119 Magnetom Prisma, Magnetom Prisma FitSiemens Medical Solutions USA, Inc. · 2013 · Recalled (Class I)
- 3 generations backK181371 uMR 790Shanghai United Imaging Healthcare Co., Ltd. · 2018
- 2 generations backK191157 uMR 780, uMR 790Shanghai United Imaging Healthcare Co., Ltd. · 2019
- 1 generation backK193200 uMR OmegaShanghai United Imaging Healthcare Co., Ltd. · 2020
- This deviceK220332 uMR Omega with uWS-MR-MRSShanghai United Imaging Healthcare Co., Ltd. · 2022
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 7 · See all- K230152uMR OmegaShanghai United Imaging Healthcare Co., Ltd. · 2023 · cites it directly6descendants
- K240540uMR OmegaShanghai United Imaging Healthcare Co., Ltd. · 2024 · 2 generations on3descendants
- K243122uMR OmegaShanghai United Imaging Healthcare Co., Ltd. · 2025 · cites it directly2descendants
- K243547uMR UltraShanghai United Imaging Healthcare Co., Ltd. · 2025 · 2 generations on1descendant
- K233673uMR JupiterShanghai United Imaging Healthcare Co., Ltd. · 2024 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K971684 | Magnetom Project 047 System (Numaris 3.5 Software) | Siemens Medical Solutions USA, Inc. | 1997 | 4 |
| −14 | K032428 | Magnetom Avanto MR System | Siemens Medical Solutions USA, Inc. | 2003 | 4 |
| −13 | K041112 | Magnetom Espree System | Siemens Medical Solutions USA, Inc. | 2004 | 4 |
| −12 | K052164 | Magnetom Systems with Software Syngo MR 2006A | Siemens Medical Solutions USA, Inc. | 2005 | — |
| −11 | K062454 | Magnetom Systems - I-Class and T-Class Releases | Siemens Medi Cal Solutions, Inc. | 2006 | — |
| −10 | K072237 | Magnetom Verio | Siemens Medical Solutions USA, Inc. | 2007 | Class I |
| −9 | K082427 | Syngo MR B17 | Siemens Medical Solutions USA, Inc. | 2008 | — |
| −8 | K101347 | Magnetom Aera; Magnetom Skyra | Siemens Medical Solutions USA, Inc. | 2010 | Class I |
| −7 | K111242 | Magnetom Aera and Magnetom Skyra | Siemens Medical Solutions USA, Inc. | 2011 | 3 |
| −6 | K121434 | Software Syngo MR D13A for the Magnetom Systems Aera/Skyra/Avanto/Verio | Siemens Medi Cal Solutions, Inc. | 2012 | Class I |
| −5 | K123938 | Syngo MR B19 for Magnetom Avanto, Syngo MR B19 for Magnetom Espree, Syngo MR… | Siemens Medical Solutions USA, Inc. | 2013 | — |
| −4 | K132119 | Magnetom Prisma, Magnetom Prisma Fit | Siemens Medical Solutions USA, Inc. | 2013 | Class I |
| −3 | K181371 | uMR 790 | Shanghai United Imaging Healthcare Co., Ltd. | 2018 | — |
| −2 | K191157 | uMR 780, uMR 790 | Shanghai United Imaging Healthcare Co., Ltd. | 2019 | — |
| −1 | K193200 | uMR Omega | Shanghai United Imaging Healthcare Co., Ltd. | 2020 | — |
| 0 (this device) | K220332 | uMR Omega with uWS-MR-MRS | Shanghai United Imaging Healthcare Co., Ltd. | 2022 | — |
| +1 | K230152 | uMR Omega | Shanghai United Imaging Healthcare Co., Ltd. | 2023 | — |
| +2 | K240540 | uMR Omega | Shanghai United Imaging Healthcare Co., Ltd. | 2024 | — |
| +1 | K243122 | uMR Omega | Shanghai United Imaging Healthcare Co., Ltd. | 2025 | — |
| +2 | K243547 | uMR Ultra | Shanghai United Imaging Healthcare Co., Ltd. | 2025 | — |
| +2 | K233673 | uMR Jupiter | Shanghai United Imaging Healthcare Co., Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 3 | 0 |
| 2002 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2013 | 1 | 0 |
| 2018 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 3 | 0 |
| 2026 | 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.
4 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 LNH device
- #1 K213693 MAGNETOM Vida with syngo MR XA50Ascore 23.0 · 18 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 |
|---|---|---|---|
| * | K193200 | uMR OmegaSummary page 5…oduct Code: LNH, LLZ, QIH Regulation Number: 21 CFR 892.1000 Device Class: II 4. Identification of Predicate Devices(s) Predicate Device 510(k) Number: K193200 Device Name: uMR Omega Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device R… | 2020 |
| † | K192601 | uWS-MR | 2020 |
| † | K193176 | uMR 780 | 2020 |
What descends from it? (7)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (4 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.
- K132119Magnetom Prisma, Magnetom Prisma FitSiemens Medical Solutions USA, Inc. · 2013 · 4 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K121434Software Syngo MR D13A for the Magnetom Systems Aera/Skyra/Avanto/VerioSiemens Medi Cal Solutions, Inc. · 2012 · 5 generations back · ◆ on the line of descent in FIG. 12 Class I recalls
- K101347Magnetom Aera; Magnetom SkyraSiemens Medical Solutions USA, Inc. · 2010 · 7 generations back · ◆ on the line of descent in FIG. 12 Class I recalls
- K072237Magnetom VerioSiemens Medical Solutions USA, Inc. · 2007 · 7 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 25 years and passes through 3 companies; a new generation was cleared every 1.1 years on median.
- 15 of the 39 ancestors have a recall of any class; 4 have a Class I recall.
- Of its descendants, K230152 (Shanghai United Imaging Healthcare Co., Ltd., 2023) has gone furthest, with 6 descendants of its own.
How does its category compare?
All LNH devicesLNH System, Nuclear Magnetic Resonance Imaging: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · LNH
26in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LNH
122in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LNH
8in 2025
Class I (8 since 2007) Class II/III not classified
Adverse event reports per year · LNH
1,263in 2025
MAUDE reports naming product code LNH, 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 | 12 | 35 | 25 | 114 |
| 2008 | 19 | 53 | 12 | 167 |
| 2009 | 17 | 70 | 7 | 194 |
| 2010 | 12 | 94 | 17 | 165 |
| 2011 | 16 | 81 | 11 | 182 |
| 2012 | 22 | 89 | 5 | 170 |
| 2013 | 19 | 108 | 2 | 107 |
| 2014 | 17 | 108 | 13 | 119 |
| 2015 | 19 | 140 | 12 (2) | 113 |
| 2016 | 20 | 108 | 1 | 135 |
| 2017 | 18 | 98 | 0 | 121 |
| 2018 | 29 | 128 | 71 | 158 |
| 2019 | 26 | 62 | 5 | 158 |
| 2020 | 32 | 121 | 4 | 98 |
| 2021 | 27 | 87 | 41 | 84 |
| 2022 | 30 | 74 | 13 | 138 |
| 2023 | 30 | 124 | 10 (1) | 159 |
| 2024 | 26 | 104 | 4 | 281 |
| 2025 | 26 | 122 | 8 (5) | 1,263 |
| 2026 | 24 | 126 | 43 | — |
What is it indicated for?
The uMR Omega system is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces sagittal, transverse, coronal, and oblique cross sectional images, and spectroscopic images, and that display internal anatomical structure and/or function of the head, body and extremities. These images and the physical parameters derived from the images when interpreted by a trained physician yield information that may assist the diagnosis. Contrast…
Read the full statement (372 words)
The uMR Omega system is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces sagittal, transverse, coronal, and oblique cross sectional images, and spectroscopic images, and that display internal anatomical structure and/or function of the head, body and extremities.
These images and the physical parameters derived from the images when interpreted by a trained physician yield information that may assist the diagnosis. Contrast agents may be used depending on the region of interest of the scan.
uWS-MR is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images. It supports interpretation and evaluation of examinations within healthcare institutions. It has the following additional indications:
The MR Stitching is intended to create full-format images from overlapping MR volume data sets acquired at multiple stages.
The Dynamic application is intended to provide a general post-processing tool for time course studies.
The Image Fusion application is intended to combine two different image series so that the displayed anatomical structures match in both series.
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 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 MR Breast Evaluation application provides the user a tool to calculate parameter maps from contrast-enhanced time-course images.
The Brain Perfusion application is intended to allow the visualization of temporal variations in the dynamic susceptibility time series of MR datasets.
MR Vessel Analysis is intended to provide a tool for viewing, manipulating, and evaluating MR vascular images.
The Inner view application is intended to perform a virtual camera view through hollow structures (cavities), such as vessels.
The DCE analysis is intended to view, manipulate, and evaluate dynamic contrast-enhanced MRI images.
The United Neuro is intended to view, manipulate, and evaluate MR neurological images.
The MR Cardiac Analysis application is intended to be used for viewing, post-processing and quantitative evaluation of cardiac magnetic resonance data.
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/K220332 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220332: uMR Omega with uWS-MR-MRS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220332
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