510(k) · Cleared
ClearedMri- Magnetic Resonance Analytical Software System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medis Medical Imaging Systems BV · LNH System, Nuclear Magnetic Resonance Imaging
Cleared on Aug 30, 2000 as substantially equivalent to K993765 (Medis Medical Imaging Systems BV, 1999) after a 254-day review. Its family tree reaches back 2 generations to 1994. 68 later devices descend from it.
- Decided
- Aug 30, 2000
- Review
- 254 days
- Class
- Class II
- Product code
- LNH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K940172 (1994). 68 later devices descend from it, 8 citing it directly.
- Root · 2 generations backK940172 Cardiovascular Measurement System-CMSMedis Medical Imaging Systems, Inc. · 1994
- 1 generation backK993765 Quantitative Analysis of Left Ventricular Angiograms (QLV)Medis Medical Imaging Systems BV · 1999
- This deviceK994283 Mri- Magnetic Resonance Analytical Software SystemMedis Medical Imaging Systems BV · 2000
- Descendant · cites it directly · 28 of its ownK073194 Cmrtools and Plug-Ins Ventricular Tools & Thalassaemia ToolsCardiovascular Imaging Solutions, Ltd. · 2008
- Descendant · cites it directly · 22 of its ownK031927 GE Delta Software Option for MriGE Medical Systems · 2003
- Descendant · 2 generations on · 21 of its ownK121762 Cardiac VXGe Medical Systems, LLC · 2013 · Recalled
- Descendant · 2 generations on · 19 of its ownK140587 MR-CT VvaMedis Medical Imaging Systems BV · 2015
- Descendant · cites it directly · 13 of its ownK090833 SegmentMedviso · 2009
Showing 5 of 68 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 68 · See all- K073194Cmrtools and Plug-Ins Ventricular Tools & Thalassaemia ToolsCardiovascular Imaging Solutions, Ltd. · 2008 · cites it directly28descendants
- K031927GE Delta Software Option for MriGE Medical Systems · 2003 · cites it directly22descendants
- K121762Cardiac VXGe Medical Systems, LLC · 2013 · 2 generations on21descendants
- K140587MR-CT VvaMedis Medical Imaging Systems BV · 2015 · 2 generations on19descendants
- K090833SegmentMedviso · 2009 · cites it directly13descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K940172 | Cardiovascular Measurement System-CMS | Medis Medical Imaging Systems, Inc. | 1994 | — |
| −1 | K993765 | Quantitative Analysis of Left Ventricular Angiograms (QLV) | Medis Medical Imaging Systems BV | 1999 | — |
| 0 (this device) | K994283 | Mri- Magnetic Resonance Analytical Software System | Medis Medical Imaging Systems BV | 2000 | — |
| +1 | K073194 | Cmrtools and Plug-Ins Ventricular Tools & Thalassaemia Tools | Cardiovascular Imaging Solutions, Ltd. | 2008 | — |
| +1 | K031927 | GE Delta Software Option for Mri | GE Medical Systems | 2003 | — |
| +2 | K121762 | Cardiac VX | Ge Medical Systems, LLC | 2013 | 1 |
| +2 | K140587 | MR-CT Vva | Medis Medical Imaging Systems BV | 2015 | — |
| +1 | K090833 | Segment | Medviso | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 3 | 0 |
| 2011 | 3 | 0 |
| 2012 | 2 | 0 |
| 2013 | 3 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 3 | 0 |
| 2017 | 2 | 0 |
| 2018 | 5 | 0 |
| 2019 | 1 | 0 |
| 2020 | 4 | 0 |
| 2021 | 6 | 0 |
| 2022 | 6 | 0 |
| 2023 | 4 | 0 |
| 2024 | 6 | 0 |
| 2025 | 5 | 0 |
| 2026 | 4 | 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 |
|---|---|---|---|
| * | K993765 | Quantitative Analysis of Left Ventricular Angiograms (QLV)Summary page 1…e System Common Name : MASS Device Class. Name : System, Image Processing; Regulation Number : 21 CFR 852.2050 (90 LLZ; Cilass [l) 3) Predicate Device(s) : Medis: 510(k) K993765; 4) Description of the device: MASS is a professional state-of-the-art analytical software tool designed for UNIX as . well as L… | 1999 |
What descends from it? (68)
See all 688 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K073194 | Cmrtools and Plug-Ins Ventricular Tools & Thalassaemia Tools | 2008 | 28 |
| K031927 | GE Delta Software Option for Mri | 2003 | 22 |
| K090833 | Segment | 2009 | 13 |
| K082628 | CMR42 Cardiac Mri Imaging System, 2.1.23 | 2008 | 12 |
| K043271 | R2-Mri Analysis System | 2005 | 7 |
| K060941 | Caas MRV Version 3.0 | 2006 | 4 |
| K041682 | Caas MRV | 2004 | 1 |
| K082526 | Cardio Vue Quantitative Analysis (CVQ) | 2009 | 0 |
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?
- The line of descent spans 6 years and passes through 2 companies; a new generation was cleared every 5.2 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K073194 (Cardiovascular Imaging Solutions, Ltd., 2008) has gone furthest, with 28 descendants of its own.
- 3 other devices also cite its predicate K993765.
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?
MASS, including its option, has been developed for the objective and reproducible analysis of multi-slice, multi-phase left and right ventricular function from cardiac MR data sets. The MASS software package can be used to semi-automatically calculate and display various parameters such as: EDV, ESV, stroke volume, ejection fraction; peak ejection and filling rates; myocardial mass; regional wall thickness, as well as wall thickening/thinning, and regional wall motion.
When interpreted by a trained physician these parameters may be useful in supporting the determination of a 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/K994283 · printed Nov 6, 2026
Cite this page
510(k) Report. “K994283: Mri- Magnetic Resonance Analytical Software System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K994283
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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