510(k) · Cleared
ClearedLiverMultiScan v5 (LMSv5)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Perspectum · LNH System, Nuclear Magnetic Resonance Imaging
Cleared on Sep 6, 2022 as substantially equivalent to K202170 (Perspectum, Ltd., 2020) and 1 other predicate after a 263-day review. Its family tree reaches back 15 generations to 1997. 3 of the 44 devices in its family, counting itself, have a Class I recall. 1 later device descends from it.
- Decided
- Sep 6, 2022
- Review
- 263 days
- Class
- Class II
- Product code
- LNH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 15 generations to K971684 (1997). 42 ancestors in all, the oldest K932271 (1994). 1 later device descends from it, 1 citing it directly. 3 of the 44 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 backK172685 LiverMultiScanPerspectum Diagnostics, Ltd. · 2017
- 2 generations backK190017 LiverMultiScan (LMSv3)Perspectum Diagnostics, Ltd. · 2019
- 1 generation backK202170 LiverMultiScanPerspectum, Ltd. · 2020
- This deviceK213960 LiverMultiScan v5 (LMSv5)Perspectum · 2022
- Descendant · cites it directly · 0 of its ownK253413 LiverMultiScan (v6.0)Perspectum, Ltd. · 2026
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 backK141977 Magnetom Aera with Software Syngo MR E11A, Magnetom Skyra with…Siemens Medical Solutions USA, Inc. · 2014
- 4 generations backK143020 LiverMultiScanMirada Medical, Ltd. · 2015
- 3 generations backK172685 LiverMultiScanPerspectum Diagnostics, Ltd. · 2017
- 2 generations backK190017 LiverMultiScan (LMSv3)Perspectum Diagnostics, Ltd. · 2019
- 1 generation backK202170 LiverMultiScanPerspectum, Ltd. · 2020
- This deviceK213960 LiverMultiScan v5 (LMSv5)Perspectum · 2022
Class I recalls in this family
Most influential descendants
Showing 1 of 1 · See all- K253413LiverMultiScan (v6.0)Perspectum, Ltd. · 2026 · cites it directly0descendants
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 | K141977 | Magnetom Aera with Software Syngo MR E11A, Magnetom Skyra with Software Syngo… | Siemens Medical Solutions USA, Inc. | 2014 | — |
| −4 | K143020 | LiverMultiScan | Mirada Medical, Ltd. | 2015 | — |
| −3 | K172685 | LiverMultiScan | Perspectum Diagnostics, Ltd. | 2017 | — |
| −2 | K190017 | LiverMultiScan (LMSv3) | Perspectum Diagnostics, Ltd. | 2019 | — |
| −1 | K202170 | LiverMultiScan | Perspectum, Ltd. | 2020 | — |
| 0 (this device) | K213960 | LiverMultiScan v5 (LMSv5) | Perspectum | 2022 | — |
| +1 | K253413 | LiverMultiScan (v6.0) | Perspectum, Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 3 | 0 |
| 2000 | 3 | 0 |
| 2001 | 3 | 0 |
| 2002 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 4 | 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 |
|---|---|---|
| 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.
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? (2)
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 |
|---|---|---|---|
| * | K202170 | LiverMultiScanSummary page 4…Subject Device Primary Predicate Device Secondary Predicate Device 510(k) number Not known K202170 K043271 Legal Manufacturer Perspectum Ltd. Perspectum Ltd. Inner Vision Bio… | 2020 |
| * | K043271 | R2-Mri Analysis SystemSummary page 4…ct Device Primary Predicate Device Secondary Predicate Device 510(k) number Not known K202170 K043271 Legal Manufacturer Perspectum Ltd. Perspectum Ltd. Inner Vision Biometrics Pty Owner/Owner Ope… | 2005 |
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 |
|---|---|---|---|
| K253413 | LiverMultiScan (v6.0) | 2026 | 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 · 6 generations back · ◆ on the line of descent in FIG. 12 Class I recalls
- K101347Magnetom Aera; Magnetom SkyraSiemens Medical Solutions USA, Inc. · 2010 · 8 generations back · ◆ on the line of descent in FIG. 12 Class I recalls
- K072237Magnetom VerioSiemens Medical Solutions USA, Inc. · 2007 · 8 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 6 companies; a new generation was cleared every 1.2 years on median.
- 14 of the 42 ancestors have a recall of any class; 3 have a Class I recall.
- Of its descendants, K253413 (Perspectum, Ltd., 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K202170.
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?
LiverMultiScan v5 (LMSv5) is indicated for use as a magnetic resonance diagnostic device software application for non-invasive liver evaluation that enables the generation, display and review of 2D magnetic resonance medical image data and pixel maps for MR relaxation times. LMSVS is designed to utilize DICOM 3.0 compliant magnetic resonance image datasets, acquired from compatible MR Systems, to display the internal structure of the abdomen including…
Read the full statement (156 words)
LiverMultiScan v5 (LMSv5) is indicated for use as a magnetic resonance diagnostic device software application for non-invasive liver evaluation that enables the generation, display and review of 2D magnetic resonance medical image data and pixel maps for MR relaxation times.
LMSVS is designed to utilize DICOM 3.0 compliant magnetic resonance image datasets, acquired from compatible MR Systems, to display the internal structure of the abdomen including the liver. Other physical parameters derived from the images may also be produced.
LMSVS provides several tools, such as automated liver segmentation and region of interest (ROI) placements, to be used for the assessment of selected regions of an image. Quantitative assessment of selected regions includes the determination of triglyceride fat fraction in the liver (PDFF), T2*, LIC (Liver Iron Concentration) and iron corrected T1 (cT1) measurements.
These images and the physical parameters derived from the images, when interpreted by a trained clinician, yield information that may assist in diagnosis.
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/K213960 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213960: LiverMultiScan v5 (LMSv5).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213960
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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