510(k) · Cleared
ClearedMAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Vida Fit; MAGNETOM Flow.Elite; MAGNETOM Flow.Neo; MAGNETOM Flow.Rise
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Healthcare GmbH · LNH System, Nuclear Magnetic Resonance Imaging
Cleared on Dec 19, 2025 as substantially equivalent to K231560 (Siemens Medical Solutions USA, Inc., 2023) and 2 other predicates after a 105-day review. Its family tree reaches back 23 generations to 1997. 11 of the 202 devices in its family, counting itself, have a Class I recall. 1 later device descends from it.
- Decided
- Dec 19, 2025
- Review
- 105 days
- Class
- Class II
- Product code
- LNH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 23 generations to K971684 (1997). 200 ancestors in all, the oldest K837107 (1983). 1 later device descends from it, 1 citing it directly. 11 of the 202 devices in this family, counting this one, have a Class I recall.
- Root · 23 generations backK971684 Magnetom Project 047 System (Numaris 3.5 Software)Siemens Medical Solutions USA, Inc. · 1997 · Recalled
- 19 generations between
- 3 generations backK232482 MAGNETOM Viato.MobileSiemens Medical Solutions USA, Inc. · 2023
- 2 generations backK240608 MAGNETOM Viato.MobileSiemens Medical Solutions USA, Inc. · 2024
- 1 generation backK250443 MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM…Siemens Healthcare GmbH · 2025 · Recalled (Class I)
- This deviceK252838 MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM…Siemens Healthcare GmbH · 2025
- Descendant · cites it directly · 0 of its ownK260852 MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM…Siemens Healthineers AG · 2026
Show all 23 generations
- Root · 23 generations backK971684 Magnetom Project 047 System (Numaris 3.5 Software)Siemens Medical Solutions USA, Inc. · 1997 · Recalled
- 22 generations backK032428 Magnetom Avanto MR SystemSiemens Medical Solutions USA, Inc. · 2003 · Recalled
- 21 generations backK041112 Magnetom Espree SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 20 generations backK052164 Magnetom Systems with Software Syngo MR 2006ASiemens Medical Solutions USA, Inc. · 2005
- 19 generations backK062454 Magnetom Systems - I-Class and T-Class ReleasesSiemens Medi Cal Solutions, Inc. · 2006
- 18 generations backK072237 Magnetom VerioSiemens Medical Solutions USA, Inc. · 2007 · Recalled (Class I)
- 17 generations backK082427 Syngo MR B17Siemens Medical Solutions USA, Inc. · 2008
- 16 generations backK101347 Magnetom Aera; Magnetom SkyraSiemens Medical Solutions USA, Inc. · 2010 · Recalled (Class I)
- 15 generations backK111242 Magnetom Aera and Magnetom SkyraSiemens Medical Solutions USA, Inc. · 2011 · Recalled
- 14 generations backK121434 Software Syngo MR D13A for the Magnetom Systems…Siemens Medi Cal Solutions, Inc. · 2012 · Recalled (Class I)
- 13 generations backK141977 Magnetom Aera with Software Syngo MR E11A, Magnetom Skyra with…Siemens Medical Solutions USA, Inc. · 2014
- 12 generations backK151579 MAGNETOM Aera (24-channel), MAGNETOM Avanto fit, MAGNETOM Skyra fit…Siemens Medical Solutions USA, Inc. · 2015 · Recalled (Class I)
- 11 generations backK153343 MAGNETOM Aera, MAGNETOM Skyra, MAGNETOM Prisma, MAGNETOM Prisma fitSiemens Medi Cal Solutions, Inc. · 2016 · Recalled (Class I)
- 10 generations backK170396 MAGNETOM VidaSiemens Medical Solutions USA, Inc. · 2017 · Recalled (Class I)
- 9 generations backK181433 MAGNETOM VidaSiemens Medical Solutions USA, Inc. · 2018
- 8 generations backK183254 Magnetom VidaSiemens Medical Solutions USA, Inc. · 2019
- 7 generations backK192924 MAGNETOM Vida, MAGNETOM Lumina, MAGNETOM Vida FitSiemens Medical Solutions USA, Inc. · 2020 · Recalled (Class I)
- 6 generations backK203443 MAGNETOM Vida, MAGNETOM Sola, MAGNETOM Lumina, MAGNETOM AlteaSiemens Medical Solutions USA, Inc. · 2021 · Recalled (Class I)
- 5 generations backK213693 MAGNETOM Vida with syngo MR XA50ASiemens Medical Solutions USA, Inc. · 2022
- 4 generations backK221733 MAGNETOM Sola, MAGNETOM Altea, MAGNETOM Sola FitSiemens Medical Solutions USA, Inc. · 2022
- 3 generations backK232482 MAGNETOM Viato.MobileSiemens Medical Solutions USA, Inc. · 2023
- 2 generations backK240608 MAGNETOM Viato.MobileSiemens Medical Solutions USA, Inc. · 2024
- 1 generation backK250443 MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM…Siemens Healthcare GmbH · 2025 · Recalled (Class I)
- This deviceK252838 MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM…Siemens Healthcare GmbH · 2025
Class I recalls in this family
Most influential descendants
Showing 1 of 1 · See all- K260852MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.PureSiemens Healthineers AG · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −23 | K971684 | Magnetom Project 047 System (Numaris 3.5 Software) | Siemens Medical Solutions USA, Inc. | 1997 | 4 |
| −22 | K032428 | Magnetom Avanto MR System | Siemens Medical Solutions USA, Inc. | 2003 | 4 |
| −21 | K041112 | Magnetom Espree System | Siemens Medical Solutions USA, Inc. | 2004 | 4 |
| −20 | K052164 | Magnetom Systems with Software Syngo MR 2006A | Siemens Medical Solutions USA, Inc. | 2005 | — |
| −19 | K062454 | Magnetom Systems - I-Class and T-Class Releases | Siemens Medi Cal Solutions, Inc. | 2006 | — |
| −18 | K072237 | Magnetom Verio | Siemens Medical Solutions USA, Inc. | 2007 | Class I |
| −17 | K082427 | Syngo MR B17 | Siemens Medical Solutions USA, Inc. | 2008 | — |
| −16 | K101347 | Magnetom Aera; Magnetom Skyra | Siemens Medical Solutions USA, Inc. | 2010 | Class I |
| −15 | K111242 | Magnetom Aera and Magnetom Skyra | Siemens Medical Solutions USA, Inc. | 2011 | 3 |
| −14 | K121434 | Software Syngo MR D13A for the Magnetom Systems Aera/Skyra/Avanto/Verio | Siemens Medi Cal Solutions, Inc. | 2012 | Class I |
| −13 | K141977 | Magnetom Aera with Software Syngo MR E11A, Magnetom Skyra with Software Syngo… | Siemens Medical Solutions USA, Inc. | 2014 | — |
| −12 | K151579 | MAGNETOM Aera (24-channel), MAGNETOM Avanto fit, MAGNETOM Skyra fit, MAGNETOM… | Siemens Medical Solutions USA, Inc. | 2015 | Class I |
| −11 | K153343 | MAGNETOM Aera, MAGNETOM Skyra, MAGNETOM Prisma, MAGNETOM Prisma fit | Siemens Medi Cal Solutions, Inc. | 2016 | Class I |
| −10 | K170396 | MAGNETOM Vida | Siemens Medical Solutions USA, Inc. | 2017 | Class I |
| −9 | K181433 | MAGNETOM Vida | Siemens Medical Solutions USA, Inc. | 2018 | — |
| −8 | K183254 | Magnetom Vida | Siemens Medical Solutions USA, Inc. | 2019 | — |
| −7 | K192924 | MAGNETOM Vida, MAGNETOM Lumina, MAGNETOM Vida Fit | Siemens Medical Solutions USA, Inc. | 2020 | Class I |
| −6 | K203443 | MAGNETOM Vida, MAGNETOM Sola, MAGNETOM Lumina, MAGNETOM Altea | Siemens Medical Solutions USA, Inc. | 2021 | Class I |
| −5 | K213693 | MAGNETOM Vida with syngo MR XA50A | Siemens Medical Solutions USA, Inc. | 2022 | — |
| −4 | K221733 | MAGNETOM Sola, MAGNETOM Altea, MAGNETOM Sola Fit | Siemens Medical Solutions USA, Inc. | 2022 | — |
| −3 | K232482 | MAGNETOM Viato.Mobile | Siemens Medical Solutions USA, Inc. | 2023 | — |
| −2 | K240608 | MAGNETOM Viato.Mobile | Siemens Medical Solutions USA, Inc. | 2024 | — |
| −1 | K250443 | MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM… | Siemens Healthcare GmbH | 2025 | Class I |
| 0 (this device) | K252838 | MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile… | Siemens Healthcare GmbH | 2025 | — |
| +1 | K260852 | MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.Pure | Siemens Healthineers AG | 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 | 6 | 0 |
| 1992 | 2 | 0 |
| 1993 | 2 | 0 |
| 1994 | 5 | 0 |
| 1995 | 5 | 0 |
| 1996 | 9 | 0 |
| 1997 | 8 | 0 |
| 1998 | 12 | 0 |
| 1999 | 6 | 0 |
| 2000 | 11 | 0 |
| 2001 | 18 | 0 |
| 2002 | 14 | 0 |
| 2003 | 8 | 0 |
| 2004 | 15 | 0 |
| 2005 | 10 | 0 |
| 2006 | 10 | 0 |
| 2007 | 8 | 0 |
| 2008 | 3 | 0 |
| 2009 | 5 | 0 |
| 2010 | 2 | 0 |
| 2011 | 3 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 2 | 1 |
| 2023 | 2 | 1 |
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.
11 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? (3)
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 |
|---|---|---|---|
| * | K231560 | MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Aera; MAGNETOM Skyra; MAGNETOM Prisma; MAGNETOM…Summary page 7…Secondary: LNI, MOS 4. Legally Marketed Predicate and Reference Device 4.1. Predicate Device Trade name: MAGNETOM Vida 510(k) Number: K231560 Classification Name: Magnetic Resonance Diagnostic Device (MRDD) Classification Panel: Radiology CFR Code:… | 2023 |
| * | K232535 | MAGNETOM Sola; MAGNETOM AlteaSummary page 7…II Product Code: Primary: LNH Secondary: LNI, MOS Trade name: MAGNETOM Sola 510(k) Number: K232535 Classification Name: Magnetic Resonance Diagnostic Device (MRDD) Classification Panel: Radiology CFR Code:… | 2023 |
| * | K250443 | MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.MobileSummary page 8…I Product Code: Primary: LNH Secondary: LNI, MOS Trade name: MAGNETOM Viato.Mobile 510(k) Number: K250443 Classification Name: Magnetic Resonance Diagnostic Device (MRDD) Classification Panel: Radiology CFR Code:… | 2025 |
| † | K220939 | MAGNETOM Lumina and MAGNETOM Vida Fit with syngo MR XA50A | 2022 |
| † | K250436 | MAGNETOM Flow.Ace; MAGNETOM Flow.Plus | 2025 |
| † | K231617 | MAGNETOM Free.Max; MAGNETOM Free.Star | 2023 |
| † | K191040 | syngo.via (Version VB40A) | 2019 |
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 |
|---|---|---|---|
| K260852 | MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.Pure | 2026 | 0 |
Has anything in its family been recalled? (11 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.
- K250443MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.MobileSiemens Healthcare GmbH · 2025 · Direct predicate · ◆ on the line of descent in FIG. 12 Class I recalls
- K231560MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Aera; MAGNETOM Skyra; MAGNETOM Prisma; MAGNETOM Prisma fitSiemens Medical Solutions USA, Inc. · 2023 · Direct predicate · ◆ in the 2023 ancestors bar of FIG. 14 Class I recalls
- K220589MAGNETOM Skyra FitSiemens Medical Solutions USA, Inc. · 2022 · 2 generations back · ◆ in the 2022 ancestors bar of FIG. 12 Class I recalls
- K203443MAGNETOM Vida, MAGNETOM Sola, MAGNETOM Lumina, MAGNETOM AlteaSiemens Medical Solutions USA, Inc. · 2021 · 3 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K192924MAGNETOM Vida, MAGNETOM Lumina, MAGNETOM Vida FitSiemens Medical Solutions USA, Inc. · 2020 · 4 generations back · ◆ on the line of descent in FIG. 12 Class I recalls
- 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
- K170396MAGNETOM VidaSiemens Medical Solutions USA, Inc. · 2017 · 7 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- 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
- K153343MAGNETOM Aera, MAGNETOM Skyra, MAGNETOM Prisma, MAGNETOM Prisma fitSiemens Medi Cal Solutions, Inc. · 2016 · 8 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K151579MAGNETOM Aera (24-channel), MAGNETOM Avanto fit, MAGNETOM Skyra fit, MAGNETOM Prisma, MAGNETOM Prisma fitSiemens Medical Solutions USA, Inc. · 2015 · 9 generations back · ◆ on the line of descent in FIG. 12 Class I recalls
Nearest 5 of 11; all are on the web page.
What does this lineage say?
- The line of descent spans 28 years and passes through 3 companies; a new generation was cleared every 1.1 years on median.
- 51 of the 200 ancestors have a recall of any class; 11 have a Class I recall.
- Of its descendants, K260852 (Siemens Healthineers AG, 2026) 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?
Indications for Use for MAGNETOM Vida, MAGNETOM Lumina, MAGNETOM Vida Fit, MAGNETOM Sola, MAGNETOM Altea, MAGNETOM Sola Fit, MAGNETOM Viato.Mobile: The MAGNETOM system is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra, and that displays the internal structure and/or function of the head, body, or extremities. Other…
Read the full statement (282 words)
Indications for Use for MAGNETOM Vida, MAGNETOM Lumina, MAGNETOM Vida Fit, MAGNETOM Sola, MAGNETOM Altea, MAGNETOM Sola Fit, MAGNETOM Viato.Mobile:
The MAGNETOM system is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra, and that displays the internal structure and/or function of the head, body, or extremities. Other physical parameters derived from the images and/or spectra may also be produced. Depending on the region of interest, contrast agents may be used. These images and/or spectra and the physical parameters derived from the images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.
The MAGNETOM system may also be used for imaging during interventional procedures when performed with MR compatible devices such as in-room displays and MR Safe biopsy needles.
Indications for Use for MAGNETOM Flow.Elite, MAGNETOM Flow.Neo, MAGNETOM Flow.Rise:
The MAGNETOM system is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra, and that displays, depending on optional local coils that have been configured with the system, the internal structure and/or function of the head, body, or extremities. Other physical parameters derived from the images and/or spectra may also be produced. Depending on the region of interest, contrast agents may be used. These images and/or spectra and the physical parameters derived from the images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.
The MAGNETOM system may also be used for imaging during interventional procedures when performed with MR compatible devices such as in-room displays and MR Safe biopsy needles.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252838 · printed Nov 5, 2026
Cite this page
510(k) Report. “K252838: MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Vida Fit; MAGNETOM Flow.Elite; MAGNETOM Flow.Neo; MAGNETOM Flow.Rise.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K252838
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