510(k) · Cleared
ClearedFunctional Mri Package for Magetetom Vision MR
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Corp. · LNH System, Nuclear Magnetic Resonance Imaging
Cleared on Feb 12, 1999 after a 79-day review. The FDA summary names its predicate without a number. 20 later devices descend from it.
- Decided
- Feb 12, 1999
- Review
- 79 days
- Class
- Class II
- Product code
- LNH
- Recalls
- None
- Predicates
- 0
20 later devices descend from it, 2 citing it directly.
- This deviceK984221 Functional Mri Package for Magetetom Vision MRSiemens Corp. · 1999
- Descendant · cites it directly · 19 of its ownK031779 CadstreamConfirma, Inc. · 2003
- Descendant · cites it directly · 17 of its ownK041286 Dynacad V1.0Mri Devices Corp. · 2004
- Descendant · 2 generations on · 9 of its ownK081556 Cadstream, Version 5.0Confirma, Inc. · 2009
- Descendant · 3 generations on · 8 of its ownK092954 Cadstream Version 5Confirma, Inc. · 2009 · Recalled
- Descendant · 3 generations on · 4 of its ownK170195 QuantXQuantitative Insights, Inc. · 2017
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 20 · See all- K031779CadstreamConfirma, Inc. · 2003 · cites it directly19descendants
- K041286Dynacad V1.0Mri Devices Corp. · 2004 · cites it directly17descendants
- K081556Cadstream, Version 5.0Confirma, Inc. · 2009 · 2 generations on9descendants
- K092954Cadstream Version 5Confirma, Inc. · 2009 · 3 generations on8descendants
- K170195QuantXQuantitative Insights, Inc. · 2017 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K984221 | Functional Mri Package for Magetetom Vision MR | Siemens Corp. | 1999 | — |
| +1 | K031779 | Cadstream | Confirma, Inc. | 2003 | — |
| +1 | K041286 | Dynacad V1.0 | Mri Devices Corp. | 2004 | — |
| +2 | K081556 | Cadstream, Version 5.0 | Confirma, Inc. | 2009 | — |
| +3 | K092954 | Cadstream Version 5 | Confirma, Inc. | 2009 | 3 |
| +3 | K170195 | QuantX | Quantitative Insights, Inc. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2009 | 4 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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? (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 |
|---|---|---|---|
| * | — | Magnetom Vision Named without a submission number | |
| * | — | Magnetom Symphony Named without a submission number |
What descends from it? (20)
See all 202 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, K031779 (Confirma, Inc., 2003) has gone furthest, with 19 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 BOLD MRI Package for MAGNETOM VISION and SYMPHONY MR systems, provides dedicated acquisition and reconstruction techniques which offer the possibility of visualization of small susceptibility changes, due to increased levels of oxygen, by parametric images. The parametric images provide parameter information, instead of anatomical information. These parametric images can be overlaid on the anatomical images to optimize the presentation of information to support the diagnostic process. These BOLD images when interpreted by a trained physician, 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/K984221 · printed Nov 6, 2026
Cite this page
510(k) Report. “K984221: Functional Mri Package for Magetetom Vision MR.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K984221
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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