510(k) · Cleared
Recalled · Class I · 2025Magnetom Prisma, Magnetom Prisma Fit
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 Nov 22, 2013 as substantially equivalent to K123510 (Siemens Medical Solutions USA, Inc., 2013) and 1 other predicate after a 136-day review. Its family tree reaches back 11 generations to 1997. 4 of the 47 devices in its family, counting itself, have a Class I recall. 12 later devices descend from it. It has been recalled 2 times, including a Class I recall.
- Decided
- Nov 22, 2013
- Review
- 136 days
- Class
- Class II
- Product code
- LNH
- Recalls
- 2 (1 Class I)
- Predicates
- 2
Its longest line of descent runs back 11 generations to K971684 (1997). 34 ancestors in all, the oldest K932271 (1994). 12 later devices descend from it, 1 citing it directly. 4 of the 47 devices in this family, counting this one, have a Class I recall.
- Root · 11 generations backK971684 Magnetom Project 047 System (Numaris 3.5 Software)Siemens Medical Solutions USA, Inc. · 1997 · Recalled
- 7 generations between
- 3 generations backK111242 Magnetom Aera and Magnetom SkyraSiemens Medical Solutions USA, Inc. · 2011 · Recalled
- 2 generations backK121434 Software Syngo MR D13A for the Magnetom Systems…Siemens Medi Cal Solutions, Inc. · 2012 · Recalled (Class I)
- 1 generation backK123938 Syngo MR B19 for Magnetom Avanto, Syngo MR B19 for Magnetom Espree…Siemens Medical Solutions USA, Inc. · 2013
- This deviceK132119 Magnetom Prisma, Magnetom Prisma FitSiemens Medical Solutions USA, Inc. · 2013
- Descendant · cites it directly · 11 of its ownK181371 uMR 790Shanghai United Imaging Healthcare Co., Ltd. · 2018
- Descendant · 2 generations on · 10 of its ownK191157 uMR 780, uMR 790Shanghai United Imaging Healthcare Co., Ltd. · 2019
- Descendant · 3 generations on · 8 of its ownK193200 uMR OmegaShanghai United Imaging Healthcare Co., Ltd. · 2020
- Descendant · 4 generations on · 7 of its ownK220332 uMR Omega with uWS-MR-MRSShanghai United Imaging Healthcare Co., Ltd. · 2022
- Descendant · 5 generations on · 6 of its ownK230152 uMR OmegaShanghai United Imaging Healthcare Co., Ltd. · 2023
Show all 11 generations
- Root · 11 generations backK971684 Magnetom Project 047 System (Numaris 3.5 Software)Siemens Medical Solutions USA, Inc. · 1997 · Recalled
- 10 generations backK032428 Magnetom Avanto MR SystemSiemens Medical Solutions USA, Inc. · 2003 · Recalled
- 9 generations backK041112 Magnetom Espree SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 8 generations backK052164 Magnetom Systems with Software Syngo MR 2006ASiemens Medical Solutions USA, Inc. · 2005
- 7 generations backK062454 Magnetom Systems - I-Class and T-Class ReleasesSiemens Medi Cal Solutions, Inc. · 2006
- 6 generations backK072237 Magnetom VerioSiemens Medical Solutions USA, Inc. · 2007 · Recalled (Class I)
- 5 generations backK082427 Syngo MR B17Siemens Medical Solutions USA, Inc. · 2008
- 4 generations backK101347 Magnetom Aera; Magnetom SkyraSiemens Medical Solutions USA, Inc. · 2010 · Recalled (Class I)
- 3 generations backK111242 Magnetom Aera and Magnetom SkyraSiemens Medical Solutions USA, Inc. · 2011 · Recalled
- 2 generations backK121434 Software Syngo MR D13A for the Magnetom Systems…Siemens Medi Cal Solutions, Inc. · 2012 · Recalled (Class I)
- 1 generation backK123938 Syngo MR B19 for Magnetom Avanto, Syngo MR B19 for Magnetom Espree…Siemens Medical Solutions USA, Inc. · 2013
- This deviceK132119 Magnetom Prisma, Magnetom Prisma FitSiemens Medical Solutions USA, Inc. · 2013
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 12 · See all- K181371uMR 790Shanghai United Imaging Healthcare Co., Ltd. · 2018 · cites it directly11descendants
- K191157uMR 780, uMR 790Shanghai United Imaging Healthcare Co., Ltd. · 2019 · 2 generations on10descendants
- K193200uMR OmegaShanghai United Imaging Healthcare Co., Ltd. · 2020 · 3 generations on8descendants
- K220332uMR Omega with uWS-MR-MRSShanghai United Imaging Healthcare Co., Ltd. · 2022 · 4 generations on7descendants
- K230152uMR OmegaShanghai United Imaging Healthcare Co., Ltd. · 2023 · 5 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K971684 | Magnetom Project 047 System (Numaris 3.5 Software) | Siemens Medical Solutions USA, Inc. | 1997 | 4 |
| −10 | K032428 | Magnetom Avanto MR System | Siemens Medical Solutions USA, Inc. | 2003 | 4 |
| −9 | K041112 | Magnetom Espree System | Siemens Medical Solutions USA, Inc. | 2004 | 4 |
| −8 | K052164 | Magnetom Systems with Software Syngo MR 2006A | Siemens Medical Solutions USA, Inc. | 2005 | — |
| −7 | K062454 | Magnetom Systems - I-Class and T-Class Releases | Siemens Medi Cal Solutions, Inc. | 2006 | — |
| −6 | K072237 | Magnetom Verio | Siemens Medical Solutions USA, Inc. | 2007 | Class I |
| −5 | K082427 | Syngo MR B17 | Siemens Medical Solutions USA, Inc. | 2008 | — |
| −4 | K101347 | Magnetom Aera; Magnetom Skyra | Siemens Medical Solutions USA, Inc. | 2010 | Class I |
| −3 | K111242 | Magnetom Aera and Magnetom Skyra | Siemens Medical Solutions USA, Inc. | 2011 | 3 |
| −2 | K121434 | Software Syngo MR D13A for the Magnetom Systems Aera/Skyra/Avanto/Verio | Siemens Medi Cal Solutions, Inc. | 2012 | Class I |
| −1 | K123938 | Syngo MR B19 for Magnetom Avanto, Syngo MR B19 for Magnetom Espree, Syngo MR… | Siemens Medical Solutions USA, Inc. | 2013 | — |
| 0 (this device) | K132119 | Magnetom Prisma, Magnetom Prisma Fit | Siemens Medical Solutions USA, Inc. | 2013 | — |
| +1 | K181371 | uMR 790 | Shanghai United Imaging Healthcare Co., Ltd. | 2018 | — |
| +2 | K191157 | uMR 780, uMR 790 | Shanghai United Imaging Healthcare Co., Ltd. | 2019 | — |
| +3 | K193200 | uMR Omega | Shanghai United Imaging Healthcare Co., Ltd. | 2020 | — |
| +4 | K220332 | uMR Omega with uWS-MR-MRS | Shanghai United Imaging Healthcare Co., Ltd. | 2022 | — |
| +5 | K230152 | uMR Omega | Shanghai United Imaging Healthcare Co., Ltd. | 2023 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2022 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K123510 | Magnetom SkyraSummary page 2…-FDA Clearance FDA Clearance Number ,Date Siemens MAGNETOM Skyra (3 T) MR K123510 May 17, 2013 system with syngo®)MR D13D Siemens MAGNETOM Trio a Tim System (TaTS) (3 T) MR System with synga® MR… | 2013 |
| * | K123938 | Syngo MR B19 for Magnetom Avanto, Syngo MR B19 for Magnetom Espree, Syngo MR B19 for…Summary page 2…3 T) MR K123510 May 17, 2013 system with syngo®)MR D13D Siemens MAGNETOM Trio a Tim System (TaTS) (3 T) MR System with synga® MR K1 23938 February 12, 2013 619 Safety and Effectiveness Siemens 510(k) Premarket Notification SIEMENS The dev… | 2013 |
What descends from it? (12)
See all 121 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K181371 | uMR 790 | 2018 | 11 |
Has anything in its family been recalled? (4 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 28, 2025 | Class I | Z-2659-2025 | Under Investigation by firm | There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within… |
| Jul 9, 2019 | Class II | Z-2345-2019 | Device Design | Potential of an open port in the quench venting system when using the optional horizontal outlet on the quench line assembly. |
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 · 2 generations back · ◆ on the line of descent in FIG. 12 Class I recalls
- K072237Magnetom VerioSiemens Medical Solutions USA, Inc. · 2007 · 3 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K101347Magnetom Aera; Magnetom SkyraSiemens Medical Solutions USA, Inc. · 2010 · 4 generations back · ◆ on the line of descent in FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 16 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, K181371 (Shanghai United Imaging Healthcare Co., Ltd., 2018) has gone furthest, with 11 descendants of its own.
- 2 other devices also cite its predicate K123510.
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. 2013, 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 Prisms and MAGNETOM Prismafit systems are indicated for use assa magnetic resonance diagnostic device (MRDD) that produces transverse, sagitlal, 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…
Read the full statement (127 words)
The MAGNETOM Prisms and MAGNETOM Prismafit systems are indicated for use assa magnetic resonance diagnostic device (MRDD) that produces transverse, sagitlal, 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 Prisma and MAGNETOM Prismafit systems may also be used for imaging during interventionall procedures when performed with MR compatible devices such as in-room display and MR Safe biopsy needles.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132119 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132119: Magnetom Prisma, Magnetom Prisma Fit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132119
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