510(k) · Cleared
Recalled · 20083TP Software Option
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
3tp, LLC · LNH System, Nuclear Magnetic Resonance Imaging
Cleared on Jun 23, 2003 as substantially equivalent to K960265 (GE Medical Systems, 1996) and 2 other predicates after a 55-day review. Its family tree reaches back 3 generations to 1991. 19 later devices descend from it. It has been recalled once.
- Decided
- Jun 23, 2003
- Review
- 55 days
- Class
- Class II
- Product code
- LNH
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 3 generations to K913475 (1991). 7 ancestors in all. 19 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK913475 Magnetic Resonance Diagnostic DeviceGE Medical Systems · 1991
- 2 generations backK960265 Advantage Windows with Functool OptionGE Medical Systems · 1996 · Recalled
- 1 generation backK971965 Philips EasyvisionPhilips Medical Systems, Inc. · 1998
- This deviceK031350 3TP Software Option3tp, LLC · 2003
- Descendant · cites it directly · 17 of its ownK041286 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
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- K041286Dynacad V1.0Mri Devices Corp. · 2004 · cites it directly17descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K913475 | Magnetic Resonance Diagnostic Device | GE Medical Systems | 1991 | — |
| −2 | K960265 | Advantage Windows with Functool Option | GE Medical Systems | 1996 | 1 |
| −1 | K971965 | Philips Easyvision | Philips Medical Systems, Inc. | 1998 | — |
| 0 (this device) | K031350 | 3TP Software Option | 3tp, LLC | 2003 | — |
| +1 | 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 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 1 | 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? (3)
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 |
|---|---|---|---|
| * | K960265 | Advantage Windows with Functool OptionSummary page 1…vantage Windows GE Prostate Spectroscopy Philips Easyvision With Functool Option and Imaging Exam (PROSE) (Quantitative Analysis (K960265) (KO 1 1 604) Option) (K97 1965) GE Medical Systems GE Medical Systems… | 1996 |
| * | K011604 | Prostate Spectroscopy and Imaging Exam (Prose) Software Option for Mri | 2001 |
| * | K971965 | Philips EasyvisionSummary page 1…ision With Functool Option and Imaging Exam (PROSE) (Quantitative Analysis (K960265) (KO 1 1 604) Option) (K97 1965) GE Medical Systems GE Medical Systems Philips Medical Systems 300 N. Grandview Blvd. 300… | 1998 |
What descends from it? (19)
See all 193 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 9, 2008 | Not classified | Z-0653-2009 | PMA | Software modules not approved for this indication. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 4.7 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K041286 (Mri Devices Corp., 2004) has gone furthest, with 17 descendants of its own.
- 12 other devices also cite its predicate K960265.
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 3TP Software Option is intended to be used as a post processing software package designed to provide a reliable means for visualizing the presence and pattern of contrast induced enhancement on MR datasets. 3TP supports the evaluation of dynamic MR data gathered during the injection of a bolus of contrast media. The resulting time course information can be displayed in a variety of formats, including a parametric image overlaid onto source MR images. In the hands of a trained physician the information provided by the 3TP Software Option could yield information that may assist in the interpretation of dynamic contrast enhanced studies.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031350 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031350: 3TP Software Option.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031350
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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