510(k) · Cleared
ClearediNtuition-T1 Mapping and T2/T2* Mapping
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Terarecon,Inc. · LLZ System, Image Processing, Radiological
Cleared on Sep 24, 2018 as substantially equivalent to K140587 (Medis Medical Imaging Systems BV, 2015) after a 168-day review. Its family tree reaches back 6 generations to 1994.
- Decided
- Sep 24, 2018
- Review
- 168 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K940172 (1994). 19 ancestors in all, the oldest K871859 (1987). No later device cites it as a predicate yet.
- Root · 6 generations backK940172 Cardiovascular Measurement System-CMSMedis Medical Imaging Systems, Inc. · 1994
- 5 generations backK993765 Quantitative Analysis of Left Ventricular Angiograms (QLV)Medis Medical Imaging Systems BV · 1999
- 4 generations backK994283 Mri- Magnetic Resonance Analytical Software SystemMedis Medical Imaging Systems BV · 2000
- 3 generations backK031927 GE Delta Software Option for MriGE Medical Systems · 2003
- 2 generations backK121762 Cardiac VXGe Medical Systems, LLC · 2013 · Recalled
- 1 generation backK140587 MR-CT VvaMedis Medical Imaging Systems BV · 2015
- This deviceK180916 iNtuition-T1 Mapping and T2/T2* MappingTerarecon,Inc. · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K940172 | Cardiovascular Measurement System-CMS | Medis Medical Imaging Systems, Inc. | 1994 | — |
| −5 | K993765 | Quantitative Analysis of Left Ventricular Angiograms (QLV) | Medis Medical Imaging Systems BV | 1999 | — |
| −4 | K994283 | Mri- Magnetic Resonance Analytical Software System | Medis Medical Imaging Systems BV | 2000 | — |
| −3 | K031927 | GE Delta Software Option for Mri | GE Medical Systems | 2003 | — |
| −2 | K121762 | Cardiac VX | Ge Medical Systems, LLC | 2013 | 1 |
| −1 | K140587 | MR-CT Vva | Medis Medical Imaging Systems BV | 2015 | — |
| 0 (this device) | K180916 | iNtuition-T1 Mapping and T2/T2* Mapping | Terarecon,Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1991 | 2 | 0 |
| 1993 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 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 LLZ? 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 LLZ device
- #1 K230955 syngo Application Softwarescore 21.5 · 11 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 |
|---|---|---|---|
| * | K140587 | MR-CT VvaSummary page 4…nd T2/T2* Mapping, as addressed in this premarket notification, is substantially equivalent to the following commercially available device: MR-CT VVA (K140587): QMass T2/T2star Analysis module and M-TOM: QMass T1 analysis module, Medis Medical Imaging Systems, b.v. In… | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
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 24 years and passes through 5 companies; a new generation was cleared every 3.7 years on median.
- 6 of the 19 ancestors have a recall of any class.
- 7 other devices also cite its predicate K140587.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · LLZ
58in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LLZ
173in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LLZ
11in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LLZ
116in 2025
MAUDE reports naming product code LLZ, 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 | 76 | 36 | 20 | 152 |
| 2008 | 94 | 52 | 32 | 154 |
| 2009 | 70 | 62 | 21 | 145 |
| 2010 | 51 | 98 | 17 | 145 |
| 2011 | 106 | 79 | 30 | 454 |
| 2012 | 82 | 87 | 12 | 266 |
| 2013 | 95 | 84 | 64 | 1,130 |
| 2014 | 78 | 89 | 6 | 15,631 |
| 2015 | 64 | 90 | 16 | 211 |
| 2016 | 82 | 90 | 12 | 290 |
| 2017 | 78 | 107 | 5 | 104 |
| 2018 | 104 | 105 | 7 | 72 |
| 2019 | 74 | 107 | 2 | 88 |
| 2020 | 81 | 115 | 6 | 82 |
| 2021 | 83 | 116 | 3 | 70 |
| 2022 | 65 | 137 | 4 | 28 |
| 2023 | 87 | 157 | 8 | 26 |
| 2024 | 62 | 131 | 6 | 42 |
| 2025 | 58 | 173 | 11 | 116 |
| 2026 | 45 | 110 | 14 | — |
What is it indicated for?
iNtuition-T1 Mapping and T2/T2* Mapping are software modules that support the derivation and quantification of T1, T2 and T2* values from MR DICOM image pixel intensities and header information. The quantification of these parameters can be used to characterize tissues. Support is provided to overlay the T1, T2, and T2* values using colormaps on related MR images. Support is provided for using different colormaps to overlay different ranges of T1, T2 or…
Read the full statement (235 words)
iNtuition-T1 Mapping and T2/T2* Mapping are software modules that support the derivation and quantification of T1, T2 and T2* values from MR DICOM image pixel intensities and header information. The quantification of these parameters can be used to characterize tissues. Support is provided to overlay the T1, T2, and T2* values using colormaps on related MR images.
Support is provided for using different colormaps to overlay different ranges of T1, T2 or T2* values and restrict the overlay to region of interest on the images. The MR images can be of simple planar scan like a single slice or volumetric or 4D scans of a body part. iNtuition-T1 Mapping and T2/T2* Mapping are iNtuition software features that can be used in multiple workflows or be used as basic tools for cardiac functionality. Additionally, the overlaid images can be captured and forwarded to other systems using standards such as DICOM or http protocol. Quantitative analysis is derived and available as text and graphical display.
iNtuition- T1 Mapping and T2/T2* Mapping qualitative results and visualization can be used in a clinical setting on MR images of an individual patient and can be used to support the clinical decision making for the diagnosis of the patient. iNtuition- T1 Mapping and T2/T2* Mapping are designed for use by healthcare professionals and are intended to assist the physician in diagnosis, who is responsible for making all final patient management decisions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180916 · printed Nov 5, 2026
Cite this page
510(k) Report. “K180916: iNtuition-T1 Mapping and T2/T2* Mapping.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K180916
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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