510(k) · Cleared
ClearedMR Vessellq Xpress
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
GE Medical Systems SCS · LLZ System, Image Processing, Radiological
Cleared on Sep 7, 2012 as substantially equivalent to K040746 (Medis Medical Imaging Systems BV, 2004) and 1 other predicate after a 49-day review. Its family tree reaches back 3 generations to 1987.
- Decided
- Sep 7, 2012
- Review
- 49 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K871859 (1987). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK871859 CT9800 Quick 3D #B7919DAGeneral Electric Co. · 1987
- 2 generations backK972399 Advantage Windows Volume Rendering OptionGe Medical Systems, Inc. · 1997 · Recalled
- 1 generation backK041521 Volume Viewer PlusGeneral Electric Medical Systems · 2004 · Recalled
- This deviceK122164 MR Vessellq XpressGE Medical Systems SCS · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K871859 | CT9800 Quick 3D #B7919DA | General Electric Co. | 1987 | — |
| −2 | K972399 | Advantage Windows Volume Rendering Option | Ge Medical Systems, Inc. | 1997 | 1 |
| −1 | K041521 | Volume Viewer Plus | General Electric Medical Systems | 2004 | 2 |
| 0 (this device) | K122164 | MR Vessellq Xpress | GE Medical Systems SCS | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 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? (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 |
|---|---|---|---|
| * | K040746 | Mra-CMSSummary page 1…Class 11 per 21 CFR 892.2050 Product Code: Picture, Archiving and Communication System LLZ Predicate Device(s): K040746 MRA-CMS by Medis Medical Imaging Systems K041521 Volume Viewer Plus by GE Medical Systems… | 2004 |
| * | K041521 | Volume Viewer PlusSummary page 1…and Communication System LLZ Predicate Device(s): K040746 MRA-CMS by Medis Medical Imaging Systems K041521 Volume Viewer Plus by GE Medical Systems MR VessellQ Xpress is a post processing analysis software… | 2004 |
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 25 years and passes through 4 companies; a new generation was cleared every 8.2 years on median.
- 4 of the 8 ancestors have a recall of any class.
- 1 other device also cites its predicate K040746.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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?
MR VesselIQ Xpress is intended to provide an optimized non-invasive application to facilitate
vascular anatomy and pathology analysis from a set of DICOM 3.0 compliant 3D contrast-
enhanced Magnetic Resonance Angiographic (MRA) images.
MR VessellQ Xpress is a post processing application which can be used in the analysis of MRA
data for the purpose of vascular disease assessment.
This software is designed to assist radiologists and other clinicians in the evaluation and
assessment of vascular anatomy and disease with the capability to provide a set of tools for
visualizing directional vessel tortuosity, for sizing the vessel and for measuring areas of
abnormalities within a vessel.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122164 · printed Nov 4, 2026
Cite this page
510(k) Report. “K122164: MR Vessellq Xpress.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K122164
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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