510(k) · Cleared
ClearedDynacad V1.0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mri Devices Corp. · LNH System, Nuclear Magnetic Resonance Imaging
Cleared on Jul 21, 2004 as substantially equivalent to K002519 (Vital Images, Inc., 2000) and 11 other predicates after a 69-day review. Its family tree reaches back 5 generations to 1996. 17 later devices descend from it.
- Decided
- Jul 21, 2004
- Review
- 69 days
- Class
- Class II
- Product code
- LNH
- Recalls
- None
- Predicates
- 12
Its longest line of descent runs back 5 generations to K954678 (1996). 23 ancestors in all, the oldest K913475 (1991). 17 later devices descend from it, 6 citing it directly.
- Root · 5 generations backK954678 Pro VisionAlgotec Systems, Ltd. · 1996
- 4 generations backK980648 Pro VisionAlgotec Systems, Ltd. · 1998
- 3 generations backK992654 Plug 'N View 3D, Version 1.0Voxar Limited · 1999
- 2 generations backK020546 Fusion 7DMirada Solutions, Ltd. · 2002
- 1 generation backK031779 CadstreamConfirma, Inc. · 2003
- This deviceK041286 Dynacad V1.0Mri Devices Corp. · 2004
- Descendant · cites it directly · 9 of its ownK081556 Cadstream, Version 5.0Confirma, Inc. · 2009
- Descendant · 2 generations on · 8 of its ownK092954 Cadstream Version 5Confirma, Inc. · 2009 · Recalled
- Descendant · 2 generations on · 4 of its ownK170195 QuantXQuantitative Insights, Inc. · 2017
- Descendant · 3 generations on · 3 of its ownK210670 BU-CADTaihao Medical, Inc. · 2021
- Descendant · 3 generations on · 2 of its ownK231130 TumorSight VizSimBioSys, Inc. · 2023
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K081556Cadstream, Version 5.0Confirma, Inc. · 2009 · cites it directly9descendants
- K092954Cadstream Version 5Confirma, Inc. · 2009 · 2 generations on8descendants
- K170195QuantXQuantitative Insights, Inc. · 2017 · 2 generations on4descendants
- K210670BU-CADTaihao Medical, Inc. · 2021 · 3 generations on3descendants
- K231130TumorSight VizSimBioSys, Inc. · 2023 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K954678 | Pro Vision | Algotec Systems, Ltd. | 1996 | — |
| −4 | K980648 | Pro Vision | Algotec Systems, Ltd. | 1998 | — |
| −3 | K992654 | Plug 'N View 3D, Version 1.0 | Voxar Limited | 1999 | — |
| −2 | K020546 | Fusion 7D | Mirada Solutions, Ltd. | 2002 | — |
| −1 | K031779 | Cadstream | Confirma, Inc. | 2003 | — |
| 0 (this device) | K041286 | Dynacad V1.0 | Mri Devices Corp. | 2004 | — |
| +1 | K081556 | Cadstream, Version 5.0 | Confirma, Inc. | 2009 | — |
| +2 | K092954 | Cadstream Version 5 | Confirma, Inc. | 2009 | 3 |
| +2 | K170195 | QuantX | Quantitative Insights, Inc. | 2017 | — |
| +3 | K210670 | BU-CAD | Taihao Medical, Inc. | 2021 | — |
| +3 | K231130 | TumorSight Viz | SimBioSys, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (12)
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 |
|---|---|---|---|
| * | K002519 | Vitrea 2, Version 2.1Summary page 1…: [email protected] Date Prepared: 17 June 2004 Name of Device Trade Name: DynaCAD TM V1.0 Classification Name: 90 LLZ Predicate Devices Vital Images, Vitrea 2 (K002519) Voxar Limited, Voxar Plug n' View 3D (K992654) Acculmage, Inc., Acculmage Display Software (K961023) Mirada Solutions Ltd, Fusio… | 2000 |
| * | K992654 | Plug 'N View 3D, Version 1.0Summary page 1…ne 2004 Name of Device Trade Name: DynaCAD TM V1.0 Classification Name: 90 LLZ Predicate Devices Vital Images, Vitrea 2 (K002519) Voxar Limited, Voxar Plug n' View 3D (K992654) Acculmage, Inc., Acculmage Display Software (K961023) Mirada Solutions Ltd, Fusion 7D (K020546) Siemens Medical Solutions, Sieme… | 1999 |
| * | K961023 | Aidp (Accuimage Image Display Processor)Summary page 1…assification Name: 90 LLZ Predicate Devices Vital Images, Vitrea 2 (K002519) Voxar Limited, Voxar Plug n' View 3D (K992654) Acculmage, Inc., Acculmage Display Software (K961023) Mirada Solutions Ltd, Fusion 7D (K020546) Siemens Medical Solutions, Siemens BOLD MRI (K984221) GE Medical Systems, GE Advantage… | 1996 |
| * | K020546 | Fusion 7DSummary page 1…es Vital Images, Vitrea 2 (K002519) Voxar Limited, Voxar Plug n' View 3D (K992654) Acculmage, Inc., Acculmage Display Software (K961023) Mirada Solutions Ltd, Fusion 7D (K020546) Siemens Medical Solutions, Siemens BOLD MRI (K984221) GE Medical Systems, GE Advantage Windows With FuncTool Option (K960265) Ph… | 2002 |
| * | K984221 | Functional Mri Package for Magetetom Vision MRSummary page 1…ar Plug n' View 3D (K992654) Acculmage, Inc., Acculmage Display Software (K961023) Mirada Solutions Ltd, Fusion 7D (K020546) Siemens Medical Solutions, Siemens BOLD MRI (K984221) GE Medical Systems, GE Advantage Windows With FuncTool Option (K960265) Philips Medical Systems, Philips EasyVision (Quantitativ… | 1999 |
| * | K960265 | Advantage Windows with Functool OptionSummary page 1…(K961023) Mirada Solutions Ltd, Fusion 7D (K020546) Siemens Medical Solutions, Siemens BOLD MRI (K984221) GE Medical Systems, GE Advantage Windows With FuncTool Option (K960265) Philips Medical Systems, Philips EasyVision (Quantitative Analysis Option) (K971965) Confirma, Inc., Accent (K013574) Confirma,… | 1996 |
| * | K971965 | Philips EasyvisionSummary page 1…ns BOLD MRI (K984221) GE Medical Systems, GE Advantage Windows With FuncTool Option (K960265) Philips Medical Systems, Philips EasyVision (Quantitative Analysis Option) (K971965) Confirma, Inc., Accent (K013574) Confirma, Inc., CADstream Version 2.0 MRI Image Processing Software (K031779) 3TP, LLC, 3TP Sof… | 1998 |
| * | K013574 | AccentSummary page 1…Systems, GE Advantage Windows With FuncTool Option (K960265) Philips Medical Systems, Philips EasyVision (Quantitative Analysis Option) (K971965) Confirma, Inc., Accent (K013574) Confirma, Inc., CADstream Version 2.0 MRI Image Processing Software (K031779) 3TP, LLC, 3TP Software Option Image Processing Sof… | 2002 |
| * | K031779 | CadstreamSummary page 1…ystems, Philips EasyVision (Quantitative Analysis Option) (K971965) Confirma, Inc., Accent (K013574) Confirma, Inc., CADstream Version 2.0 MRI Image Processing Software (K031779) 3TP, LLC, 3TP Software Option Image Processing Software for MR Devices (K031350) MRI Devices Corporation, Breast Biopsy Coil (K0… | 2003 |
| * | K031350 | 3TP Software OptionSummary page 1…., Accent (K013574) Confirma, Inc., CADstream Version 2.0 MRI Image Processing Software (K031779) 3TP, LLC, 3TP Software Option Image Processing Software for MR Devices (K031350) MRI Devices Corporation, Breast Biopsy Coil (K032576) MRI Devices Corporation, MR Biopsy (K010570) Intended Use DynaCAD is a pos… | 2003 |
| * | K032576 | Biopsy Breast Coil, Model BBCSummary page 1…2.0 MRI Image Processing Software (K031779) 3TP, LLC, 3TP Software Option Image Processing Software for MR Devices (K031350) MRI Devices Corporation, Breast Biopsy Coil (K032576) MRI Devices Corporation, MR Biopsy (K010570) Intended Use DynaCAD is a post-processing software package intended for use in view… | 2003 |
| * | K010570 | Breast Immobiization and Biopsy Device MR-Biopsy 160Summary page 1…TP, LLC, 3TP Software Option Image Processing Software for MR Devices (K031350) MRI Devices Corporation, Breast Biopsy Coil (K032576) MRI Devices Corporation, MR Biopsy (K010570) Intended Use DynaCAD is a post-processing software package intended for use in viewing and analyzing magnetic resonance imaging… | 2001 |
What descends from it? (17)
See all 176 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?
- The line of descent spans 8 years and passes through 5 companies; a new generation was cleared every 1.3 years on median.
- 5 of the 23 ancestors have a recall of any class.
- Of its descendants, K081556 (Confirma, Inc., 2009) has gone furthest, with 9 descendants of its own.
- 12 other devices also cite its predicate K002519.
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?
DynaCAD is a post-processing software package intended for use in viewing and analyzing magnetic resonance imaging (MRI) studies. DynaCAD supports evaluation of dynamic MR data acquired during contrast administration. DynaCAD automatically registers serial patient image acquisitions to minimize the impact of patient motion, segments and labels tissue types based on enhancement characteristics (parametric image maps), and performs other user-defined…
Read the full statement (203 words)
DynaCAD is a post-processing software package intended for use in viewing and analyzing magnetic resonance imaging (MRI) studies. DynaCAD supports evaluation of dynamic MR data acquired during contrast administration. DynaCAD automatically registers serial patient image acquisitions to minimize the impact of patient motion, segments and labels tissue types based on enhancement characteristics (parametric image maps), and performs other user-defined post-processing functions such as image subtractions, multiplanar reformats, and maximum intensity projections. The resulting information can be displayed in a variety of formats, including a parametric image overlaid onto the source image. DynaCAD is designed to provide a reliable means of visualizing the presence and pattern of contrast induced enhancements of MR data sets. In addition to being a Computer Aided Detection (CAD) system, DynaCAD also provides an intervention planning tool, which assists with MRI guidance of percutaneous interventional procedures.
When interpreted by a skilled physician, this device provides information that may be useful in screening, diagnosis, intervention planning and monitoring. DynaCAD can also be used to provide accurate measurements of the diameters, areas, volumes and uptake characteristics of segmented tissues in any original, registered, analyzed or reformatted image. Patient management decisions should not be made based solely on the results of DynaCAD analysis.
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/K041286 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041286: Dynacad V1.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041286
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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