510(k) · Cleared
CleareduMR 680
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 Jul 16, 2025 as substantially equivalent to K240744 (Shanghai United Imaging Healthcare Co., Ltd., 2024) after a 258-day review. Its family tree reaches back 16 generations to 1997. 3 of the 40 devices in its family, counting itself, have a Class I recall. 1 later device descends from it.
- Decided
- Jul 16, 2025
- Review
- 258 days
- Class
- Class II
- Product code
- LNH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 16 generations to K971684 (1997). 38 ancestors in all, the oldest K932271 (1994). 1 later device descends from it, 1 citing it directly. 3 of the 40 devices in this family, counting this one, have a Class I recall.
- Root · 16 generations backK971684 Magnetom Project 047 System (Numaris 3.5 Software)Siemens Medical Solutions USA, Inc. · 1997 · Recalled
- 12 generations between
- 3 generations backK201540 uMR570Shanghai United Imaging Healthcare Co., Ltd. · 2020
- 2 generations backK222755 uMR 680Shanghai United Imaging Intelligence Co., Ltd. · 2023
- 1 generation backK240744 uMR 680Shanghai United Imaging Healthcare Co., Ltd. · 2024
- This deviceK243397 uMR 680Shanghai United Imaging Healthcare Co., Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK252371 uMR 680Shanghai United Imaging Healthcare Co., Ltd. · 2025
Show all 16 generations
- Root · 16 generations backK971684 Magnetom Project 047 System (Numaris 3.5 Software)Siemens Medical Solutions USA, Inc. · 1997 · Recalled
- 15 generations backK032428 Magnetom Avanto MR SystemSiemens Medical Solutions USA, Inc. · 2003 · Recalled
- 14 generations backK041112 Magnetom Espree SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 13 generations backK052164 Magnetom Systems with Software Syngo MR 2006ASiemens Medical Solutions USA, Inc. · 2005
- 12 generations backK062454 Magnetom Systems - I-Class and T-Class ReleasesSiemens Medi Cal Solutions, Inc. · 2006
- 11 generations backK072237 Magnetom VerioSiemens Medical Solutions USA, Inc. · 2007 · Recalled (Class I)
- 10 generations backK082427 Syngo MR B17Siemens Medical Solutions USA, Inc. · 2008
- 9 generations backK101347 Magnetom Aera; Magnetom SkyraSiemens Medical Solutions USA, Inc. · 2010 · Recalled (Class I)
- 8 generations backK111242 Magnetom Aera and Magnetom SkyraSiemens Medical Solutions USA, Inc. · 2011 · Recalled
- 7 generations backK121434 Software Syngo MR D13A for the Magnetom Systems…Siemens Medi Cal Solutions, Inc. · 2012 · Recalled (Class I)
- 6 generations backK132951 Magnetom AeraSiemens Medical Solutions USA, Inc. · 2013 · Recalled
- 5 generations backK180925 uMR 570Shanghai United Imaging Healthcare Co., Ltd. · 2018
- 4 generations backK200024 uMR 570Shanghai United Imaging Healthcare Co., Ltd. · 2020
- 3 generations backK201540 uMR570Shanghai United Imaging Healthcare Co., Ltd. · 2020
- 2 generations backK222755 uMR 680Shanghai United Imaging Intelligence Co., Ltd. · 2023
- 1 generation backK240744 uMR 680Shanghai United Imaging Healthcare Co., Ltd. · 2024
- This deviceK243397 uMR 680Shanghai United Imaging Healthcare Co., Ltd. · 2025
Class I recalls in this family
Most influential descendants
Showing 1 of 1 · See all- K252371uMR 680Shanghai 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 |
|---|---|---|---|---|---|
| −16 | K971684 | Magnetom Project 047 System (Numaris 3.5 Software) | Siemens Medical Solutions USA, Inc. | 1997 | 4 |
| −15 | K032428 | Magnetom Avanto MR System | Siemens Medical Solutions USA, Inc. | 2003 | 4 |
| −14 | K041112 | Magnetom Espree System | Siemens Medical Solutions USA, Inc. | 2004 | 4 |
| −13 | K052164 | Magnetom Systems with Software Syngo MR 2006A | Siemens Medical Solutions USA, Inc. | 2005 | — |
| −12 | K062454 | Magnetom Systems - I-Class and T-Class Releases | Siemens Medi Cal Solutions, Inc. | 2006 | — |
| −11 | K072237 | Magnetom Verio | Siemens Medical Solutions USA, Inc. | 2007 | Class I |
| −10 | K082427 | Syngo MR B17 | Siemens Medical Solutions USA, Inc. | 2008 | — |
| −9 | K101347 | Magnetom Aera; Magnetom Skyra | Siemens Medical Solutions USA, Inc. | 2010 | Class I |
| −8 | K111242 | Magnetom Aera and Magnetom Skyra | Siemens Medical Solutions USA, Inc. | 2011 | 3 |
| −7 | K121434 | Software Syngo MR D13A for the Magnetom Systems Aera/Skyra/Avanto/Verio | Siemens Medi Cal Solutions, Inc. | 2012 | Class I |
| −6 | K132951 | Magnetom Aera | Siemens Medical Solutions USA, Inc. | 2013 | 1 |
| −5 | K180925 | uMR 570 | Shanghai United Imaging Healthcare Co., Ltd. | 2018 | — |
| −4 | K200024 | uMR 570 | Shanghai United Imaging Healthcare Co., Ltd. | 2020 | — |
| −3 | K201540 | uMR570 | Shanghai United Imaging Healthcare Co., Ltd. | 2020 | — |
| −2 | K222755 | uMR 680 | Shanghai United Imaging Intelligence Co., Ltd. | 2023 | — |
| −1 | K240744 | uMR 680 | Shanghai United Imaging Healthcare Co., Ltd. | 2024 | — |
| 0 (this device) | K243397 | uMR 680 | Shanghai United Imaging Healthcare Co., Ltd. | 2025 | — |
| +1 | K252371 | uMR 680 | Shanghai United Imaging Healthcare Co., Ltd. | 2025 | — |
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 |
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 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 |
|---|---|---|---|
| * | K240744 | uMR 680Summary page 5…e: LNH, MOS Secondary Product Code: QIH Review Panel: Radiology 3. Identification of Primary/Reference Device(s) Predicate Device 510(k) Number: K240744 Device Name: uMR 680 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: II Product Code:… | 2024 |
| † | K220332 | uMR Omega with uWS-MR-MRS | 2022 |
| † | K234154 | uPMR 790 | 2024 |
| † | K230152 | uMR Omega | 2023 |
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 |
|---|---|---|---|
| K252371 | uMR 680 | 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 · 7 generations back · ◆ on the line of descent in FIG. 12 Class I recalls
- K101347Magnetom Aera; Magnetom SkyraSiemens Medical Solutions USA, Inc. · 2010 · 9 generations back · ◆ on the line of descent in FIG. 12 Class I recalls
- K072237Magnetom VerioSiemens Medical Solutions USA, Inc. · 2007 · 9 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 28 years and passes through 4 companies; a new generation was cleared every 1.1 years on median.
- 15 of the 38 ancestors have a recall of any class; 3 have a Class I recall.
- Of its descendants, K252371 (Shanghai United Imaging Healthcare Co., Ltd., 2025) has gone furthest, with 0 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. 2025, 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 680 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K243397 · printed Nov 4, 2026
Cite this page
510(k) Report. “K243397: uMR 680.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K243397
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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