510(k) · Cleared
Recalled · Class II · 2014Cardiac VX
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Medical Systems, LLC · LLZ System, Image Processing, Radiological
Cleared on Jan 18, 2013 as substantially equivalent to K031927 (GE Medical Systems, 2003) and 1 other predicate after a 217-day review. Its family tree reaches back 4 generations to 1994. 21 later devices descend from it. It has been recalled once.
- Decided
- Jan 18, 2013
- Review
- 217 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 4 generations to K940172 (1994). 16 ancestors in all, the oldest K871859 (1987). 21 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK940172 Cardiovascular Measurement System-CMSMedis Medical Imaging Systems, Inc. · 1994
- 3 generations backK993765 Quantitative Analysis of Left Ventricular Angiograms (QLV)Medis Medical Imaging Systems BV · 1999
- 2 generations backK994283 Mri- Magnetic Resonance Analytical Software SystemMedis Medical Imaging Systems BV · 2000
- 1 generation backK031927 GE Delta Software Option for MriGE Medical Systems · 2003
- This deviceK121762 Cardiac VXGe Medical Systems, LLC · 2013
- Descendant · cites it directly · 19 of its ownK140587 MR-CT VvaMedis Medical Imaging Systems BV · 2015
- Descendant · 2 generations on · 5 of its ownK191125 ADAS 3DGalgo Medical S.L · 2020
- Descendant · 2 generations on · 5 of its ownK162513 Arterys Software v2.0Arterys, Inc. · 2016
- Descendant · 3 generations on · 4 of its ownK210850 ADAS 3DAdas3D Medical S.L. · 2021
- Descendant · 2 generations on · 4 of its ownK163253 Arterys Cardio DLArterys, Inc. · 2017
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K140587MR-CT VvaMedis Medical Imaging Systems BV · 2015 · cites it directly19descendants
- K191125ADAS 3DGalgo Medical S.L · 2020 · 2 generations on5descendants
- K162513Arterys Software v2.0Arterys, Inc. · 2016 · 2 generations on5descendants
- K210850ADAS 3DAdas3D Medical S.L. · 2021 · 3 generations on4descendants
- K163253Arterys Cardio DLArterys, Inc. · 2017 · 2 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K940172 | Cardiovascular Measurement System-CMS | Medis Medical Imaging Systems, Inc. | 1994 | — |
| −3 | K993765 | Quantitative Analysis of Left Ventricular Angiograms (QLV) | Medis Medical Imaging Systems BV | 1999 | — |
| −2 | K994283 | Mri- Magnetic Resonance Analytical Software System | Medis Medical Imaging Systems BV | 2000 | — |
| −1 | K031927 | GE Delta Software Option for Mri | GE Medical Systems | 2003 | — |
| 0 (this device) | K121762 | Cardiac VX | Ge Medical Systems, LLC | 2013 | — |
| +1 | K140587 | MR-CT Vva | Medis Medical Imaging Systems BV | 2015 | — |
| +2 | K191125 | ADAS 3D | Galgo Medical S.L | 2020 | — |
| +2 | K162513 | Arterys Software v2.0 | Arterys, Inc. | 2016 | — |
| +3 | K210850 | ADAS 3D | Adas3D Medical S.L. | 2021 | — |
| +2 | K163253 | Arterys Cardio DL | Arterys, Inc. | 2017 | — |
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 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 4 | 0 |
| 2020 | 3 | 0 |
| 2021 | 2 | 0 |
| 2022 | 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 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? (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 |
|---|---|---|---|
| * | K031927 | GE Delta Software Option for MriSummary page 2…510(k) Premarket Notification Submission Predicate Device(s): GE Delta Software Option for MRL (marketed as ReportCARD) (K03 1927) manufactured by GE READY View (KI 10573) manufactured by GE Device Description: CardiacVX is a post… | 2003 |
| * | K110573 | Ready View | 2011 |
What descends from it? (21)
See all 212 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 |
|---|---|---|---|---|
| Apr 7, 2014 | Class II | Z-1511-2014 | Software design | GE Healthcare has recently become aware of a potential safety issue due to higher than actual flow values reported on CardiacVX and CardiacVX Flow running on Advantage Workstation. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 years and passes through 4 companies; a new generation was cleared every 5.2 years on median.
- 5 of the 16 ancestors have a recall of any class.
- Of its descendants, K140587 (Medis Medical Imaging Systems BV, 2015) has gone furthest, with 19 descendants of its own.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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?
The GE CardiacVX for MRI is an analytical software tool, which provides reproducible tools for the review and reporting of medical images. CardiacVX can import medical images from a MR system and display them in a viewing area on the computer screen. The viewing area allows the access to multiple studies and series of multi-slice, multi-phase images. Multi-phase sequences of images can be displayed in a cine mode to facilitate visualization. A report…
Read the full statement (192 words)
The GE CardiacVX for MRI is an analytical software tool, which provides reproducible tools for the review and reporting of medical images. CardiacVX can import medical images from a MR system and display them in a viewing area on the computer screen. The viewing area allows the access to multiple studies and series of multi-slice, multi-phase images. Multi-phase sequences of images can be displayed in a cine mode to facilitate visualization.
A report input interface is also available. Measurement tools on the report interface make it possible to quickly and reliably fill out a complete clinical report of an imaging exam. Available tools include: point, distance, area, and volume measurement tools such as ejection fraction, cardiac output, end-diastolic volume, end-systolic volume, and volume flow measurements.
Semi-automatic tools are available for left ventricular contour detection, valve plane detection, vessel contour detection for flow analysis, signal intensity analysis for myocardium and infarct sizing measurement, and T2 star analysis.
The results of the measurement tools are interpreted by the physician and can be communicated to referring physicians.
When interpreted by a trained physician these tools may be useful in supporting the determination of a diagnosis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121762 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121762: Cardiac VX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121762
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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