510(k) · Cleared
ClearedMAGNETOM Terra
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Solutions USA, Inc. · LNH System, Nuclear Magnetic Resonance Imaging
Cleared on Feb 15, 2019 as substantially equivalent to K170840 (Siemens Medical Solutions USA, Inc., 2017) after an 87-day review. Its family tree reaches back 12 generations to 1997. 3 of the 36 devices in its family, counting itself, have a Class I recall. 1 later device descends from it.
- Decided
- Feb 15, 2019
- Review
- 87 days
- Class
- Class II
- Product code
- LNH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K971684 (1997). 34 ancestors in all, the oldest K932271 (1994). 1 later device descends from it, 1 citing it directly. 3 of the 36 devices in this family, counting this one, have a Class I recall.
- Root · 12 generations backK971684 Magnetom Project 047 System (Numaris 3.5 Software)Siemens Medical Solutions USA, Inc. · 1997 · Recalled
- 8 generations between
- 3 generations backK121434 Software Syngo MR D13A for the Magnetom Systems…Siemens Medi Cal Solutions, Inc. · 2012 · Recalled (Class I)
- 2 generations backK123938 Syngo MR B19 for Magnetom Avanto, Syngo MR B19 for Magnetom Espree…Siemens Medical Solutions USA, Inc. · 2013
- 1 generation backK170840 MAGNETOM TerraSiemens Medical Solutions USA, Inc. · 2017
- This deviceK183222 MAGNETOM TerraSiemens Medical Solutions USA, Inc. · 2019
- Descendant · cites it directly · 0 of its ownK232322 MAGNETOM Terra; MAGNETOM Terra.XSiemens Medical Solutions USA, Inc. · 2024
Show all 12 generations
- Root · 12 generations backK971684 Magnetom Project 047 System (Numaris 3.5 Software)Siemens Medical Solutions USA, Inc. · 1997 · Recalled
- 11 generations backK032428 Magnetom Avanto MR SystemSiemens Medical Solutions USA, Inc. · 2003 · Recalled
- 10 generations backK041112 Magnetom Espree SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 9 generations backK052164 Magnetom Systems with Software Syngo MR 2006ASiemens Medical Solutions USA, Inc. · 2005
- 8 generations backK062454 Magnetom Systems - I-Class and T-Class ReleasesSiemens Medi Cal Solutions, Inc. · 2006
- 7 generations backK072237 Magnetom VerioSiemens Medical Solutions USA, Inc. · 2007 · Recalled (Class I)
- 6 generations backK082427 Syngo MR B17Siemens Medical Solutions USA, Inc. · 2008
- 5 generations backK101347 Magnetom Aera; Magnetom SkyraSiemens Medical Solutions USA, Inc. · 2010 · Recalled (Class I)
- 4 generations backK111242 Magnetom Aera and Magnetom SkyraSiemens Medical Solutions USA, Inc. · 2011 · Recalled
- 3 generations backK121434 Software Syngo MR D13A for the Magnetom Systems…Siemens Medi Cal Solutions, Inc. · 2012 · Recalled (Class I)
- 2 generations backK123938 Syngo MR B19 for Magnetom Avanto, Syngo MR B19 for Magnetom Espree…Siemens Medical Solutions USA, Inc. · 2013
- 1 generation backK170840 MAGNETOM TerraSiemens Medical Solutions USA, Inc. · 2017
- This deviceK183222 MAGNETOM TerraSiemens Medical Solutions USA, Inc. · 2019
Class I recalls in this family
Most influential descendants
Showing 1 of 1 · See all- K232322MAGNETOM Terra; MAGNETOM Terra.XSiemens Medical Solutions USA, Inc. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K971684 | Magnetom Project 047 System (Numaris 3.5 Software) | Siemens Medical Solutions USA, Inc. | 1997 | 4 |
| −11 | K032428 | Magnetom Avanto MR System | Siemens Medical Solutions USA, Inc. | 2003 | 4 |
| −10 | K041112 | Magnetom Espree System | Siemens Medical Solutions USA, Inc. | 2004 | 4 |
| −9 | K052164 | Magnetom Systems with Software Syngo MR 2006A | Siemens Medical Solutions USA, Inc. | 2005 | — |
| −8 | K062454 | Magnetom Systems - I-Class and T-Class Releases | Siemens Medi Cal Solutions, Inc. | 2006 | — |
| −7 | K072237 | Magnetom Verio | Siemens Medical Solutions USA, Inc. | 2007 | Class I |
| −6 | K082427 | Syngo MR B17 | Siemens Medical Solutions USA, Inc. | 2008 | — |
| −5 | K101347 | Magnetom Aera; Magnetom Skyra | Siemens Medical Solutions USA, Inc. | 2010 | Class I |
| −4 | K111242 | Magnetom Aera and Magnetom Skyra | Siemens Medical Solutions USA, Inc. | 2011 | 3 |
| −3 | K121434 | Software Syngo MR D13A for the Magnetom Systems Aera/Skyra/Avanto/Verio | Siemens Medi Cal Solutions, Inc. | 2012 | Class I |
| −2 | K123938 | Syngo MR B19 for Magnetom Avanto, Syngo MR B19 for Magnetom Espree, Syngo MR… | Siemens Medical Solutions USA, Inc. | 2013 | — |
| −1 | K170840 | MAGNETOM Terra | Siemens Medical Solutions USA, Inc. | 2017 | — |
| 0 (this device) | K183222 | MAGNETOM Terra | Siemens Medical Solutions USA, Inc. | 2019 | — |
| +1 | K232322 | MAGNETOM Terra; MAGNETOM Terra.X | Siemens Medical Solutions USA, Inc. | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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 |
|---|---|---|---|
| * | K170840 | MAGNETOM TerraSummary page 7…the reference device MAGNETOM Prisma with syngo MR E11C-AP04 (cleared with K173592, February 13, 2018). Modifications to existing software syngo MR E11K (K170840). - Modified SPACE pulse sequence type with CAIPIRINHA acquisition technique named as CAIPIRINHA SPACE… | 2017 |
| † | K173592 | MAGNETOM Aera, MAGNETOM Skyra/Skyrafit, MAGNETOM Prisma/Prismafit, MAGNETOM Avantofit | 2018 |
| † | K172531 | Biograph mMR with mMR Angio Transfer Option | 2017 |
| † | K102348 | 31P/1H Dual Tuned Surface Coil 3T; 23NA/ 1H Dual Turned Surface Coil 3T; 13C /1H Dual… | 2010 |
| † | K102748 | 31P/1H Head Coil 3T; 23NA/1H Head Coil 3T; 13C/1H Head Coil 3T | 2011 |
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 |
|---|---|---|---|
| K232322 | MAGNETOM Terra; MAGNETOM Terra.X | 2024 | 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 · 3 generations back · ◆ on the line of descent in FIG. 12 Class I recalls
- K072237Magnetom VerioSiemens Medical Solutions USA, Inc. · 2007 · 4 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K101347Magnetom Aera; Magnetom SkyraSiemens Medical Solutions USA, Inc. · 2010 · 5 generations back · ◆ on the line of descent in FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 22 years and passes through 2 companies; a new generation was cleared every 1.1 years on median.
- 14 of the 34 ancestors have a recall of any class; 3 have a Class I recall.
- Of its descendants, K232322 (Siemens Medical Solutions USA, Inc., 2024) 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. 2019, 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 MAGNETOM Terra system is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, and that displays the internal structure and/or function of the head or extremities. Other physical parameters derived from the images may also be produced. Additionally the MAGNETOM Terra is intended to produce Sodium images for the head and Phosphorus spectroscopic images and/or…
Read the full statement (111 words)
The MAGNETOM Terra system is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, and that displays the internal structure and/or function of the head or extremities. Other physical parameters derived from the images may also be produced.
Additionally the MAGNETOM Terra is intended to produce Sodium images for the head and Phosphorus spectroscopic images and/or spectra for whole body, excluding the head.
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 device is intended for patients > 30 kg/66 Ibs.
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/K183222 · printed Nov 6, 2026
Cite this page
510(k) Report. “K183222: MAGNETOM Terra.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K183222
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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