510(k) · Cleared
ClearedPerfusion Package for Magnetom Vision and Symphony Systems
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 2, 1999 after a 69-day review. The FDA summary names its predicate without a number. 33 later devices descend from it.
- Decided
- Feb 2, 1999
- Review
- 69 days
- Class
- Class II
- Product code
- LNH
- Recalls
- None
- Predicates
- 0
33 later devices descend from it, 2 citing it directly.
- This deviceK984224 Perfusion Package for Magnetom Vision and Symphony SystemsSiemens Corp. · 1999
- Descendant · cites it directly · 32 of its ownK061429 Dynamic Mri Software Option for C-Scan, E-Scan XQ and E-Scan OperaEsaote, S.p.A. · 2006
- Descendant · 2 generations on · 24 of its ownK080968 S-Scan, G-Scan, Dynamic Mri Software for C-Scan, E-Scanxq & E-Scan…Esaote, S.p.A. · 2008
- Descendant · 3 generations on · 18 of its ownK092469 O-Scan MR SystemEsaote, S.p.A. · 2009
- Descendant · 3 generations on · 15 of its ownK110238 G-SCANEsaote, S.p.A. · 2011
- Descendant · 4 generations on · 14 of its ownK111803 G-SCANEsaote, S.p.A. · 2011
Showing 5 of 33 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 33 · See all- K061429Dynamic Mri Software Option for C-Scan, E-Scan XQ and E-Scan OperaEsaote, S.p.A. · 2006 · cites it directly32descendants
- K080968S-Scan, G-Scan, Dynamic Mri Software for C-Scan, E-Scanxq & E-Scan OperaEsaote, S.p.A. · 2008 · 2 generations on24descendants
- K092469O-Scan MR SystemEsaote, S.p.A. · 2009 · 3 generations on18descendants
- K110238G-SCANEsaote, S.p.A. · 2011 · 3 generations on15descendants
- K111803G-SCANEsaote, S.p.A. · 2011 · 4 generations on14descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K984224 | Perfusion Package for Magnetom Vision and Symphony Systems | Siemens Corp. | 1999 | — |
| +1 | K061429 | Dynamic Mri Software Option for C-Scan, E-Scan XQ and E-Scan Opera | Esaote, S.p.A. | 2006 | — |
| +2 | K080968 | S-Scan, G-Scan, Dynamic Mri Software for C-Scan, E-Scanxq & E-Scan Opera | Esaote, S.p.A. | 2008 | — |
| +3 | K092469 | O-Scan MR System | Esaote, S.p.A. | 2009 | — |
| +3 | K110238 | G-SCAN | Esaote, S.p.A. | 2011 | — |
| +4 | K111803 | G-SCAN | Esaote, S.p.A. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 4 | 0 |
| 2012 | 5 | 0 |
| 2013 | 3 | 0 |
| 2015 | 3 | 0 |
| 2016 | 3 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 3 | 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 MR system Named without a submission number | |
| * | — | SYMPHONY MR system Named without a submission number |
What descends from it? (33)
See all 332 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, K061429 (Esaote, S.p.A., 2006) has gone furthest, with 32 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 Perfusion Package for MAGNETOM Vision and Symphony MR Systems is a software
package which allows the display of temporal variations in dynamic MR Datasets, showing
changes in contrast over time. Its purpose is to provide either time intensity curves or the
creation of parametric images for parameters like time to peak that support the diagnostic
process. These images when interpreted by a trained physician, yield information that may
assist in diagnosis. One clinical application where this could be useful is the diagnosis of
lesions by temporal analysis of tumor enhancement.
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/K984224 · printed Nov 6, 2026
Cite this page
510(k) Report. “K984224: Perfusion Package for Magnetom Vision and Symphony Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K984224
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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