510(k) · Cleared
ClearedDiffusion Weighted MR Imaging /Magnetom Vision
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 Jun 20, 1997 after an 88-day review. The FDA summary names its predicate without a number. 8 later devices descend from it.
- Decided
- Jun 20, 1997
- Review
- 88 days
- Class
- Class II
- Product code
- LNH
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 3 citing it directly.
- This deviceK971055 Diffusion Weighted MR Imaging /Magnetom VisionSiemens Medical Solutions USA, Inc. · 1997
- Descendant · cites it directly · 4 of its ownK972990 Magnetic Resonance Diagnostic SystemGE Medical Systems · 1998
- Descendant · 2 generations on · 3 of its ownK031230 GE Propeller Imaging Option for MriGE Medical Systems · 2003
- Descendant · 3 generations on · 1 of its ownK113394 Mavric SLGe Medical Systems, LLC · 2012
- Descendant · cites it directly · 1 of its ownK974530 Duffusion-Weighted MR Imaging PackagePhilips Medical Systems (Cleveland), Inc. · 1998
- Descendant · 4 generations on · 0 of its ownK143253 O-MARPhilips Medical Systems Nederland B.V. · 2015
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K972990Magnetic Resonance Diagnostic SystemGE Medical Systems · 1998 · cites it directly4descendants
- K031230GE Propeller Imaging Option for MriGE Medical Systems · 2003 · 2 generations on3descendants
- K113394Mavric SLGe Medical Systems, LLC · 2012 · 3 generations on1descendant
- K974530Duffusion-Weighted MR Imaging PackagePhilips Medical Systems (Cleveland), Inc. · 1998 · cites it directly1descendant
- K143253O-MARPhilips Medical Systems Nederland B.V. · 2015 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K971055 | Diffusion Weighted MR Imaging /Magnetom Vision | Siemens Medical Solutions USA, Inc. | 1997 | — |
| +1 | K972990 | Magnetic Resonance Diagnostic System | GE Medical Systems | 1998 | — |
| +2 | K031230 | GE Propeller Imaging Option for Mri | GE Medical Systems | 2003 | — |
| +3 | K113394 | Mavric SL | Ge Medical Systems, LLC | 2012 | — |
| +1 | K974530 | Duffusion-Weighted MR Imaging Package | Philips Medical Systems (Cleveland), Inc. | 1998 | — |
| +4 | K143253 | O-MAR | Philips Medical Systems Nederland B.V. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 4 | 0 |
| 2003 | 1 | 0 |
| 2007 | 1 | 0 |
| 2012 | 1 | 0 |
| 2015 | 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.
Planning a device in LNH? 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 |
|---|---|---|---|
| * | — | Echo Planar Sequences Named without a submission number |
What descends from it? (8)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K972990 (GE Medical Systems, 1998) has gone furthest, with 4 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.
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 Siemens Diffusion-Weighted MR Imaging Package has been designed to image the djffusive mobility of water or other proton-containing molecules. One important clinical application is to visualize the apparent loss of mobility by water molecules in brain tissue affected by acute stroke. Areas of decreased diffusion, as is observed in acute cerebral infarcts, appear as areas of higher image intensity.
Diffusion weighted MR pulse sequences are more accurate than conventional MRI pulse sequences in identifying the occurrence of acute stroke during the first 24 hours after onset of symptoms.
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/K971055 · printed Nov 5, 2026
Cite this page
510(k) Report. “K971055: Diffusion Weighted MR Imaging /Magnetom Vision.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K971055
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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