510(k) · Cleared
ClearedMri-Q System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Resonance Health Analysis Services Pty, Ltd. · LLZ System, Image Processing, Radiological
Cleared on Jul 28, 2011 as substantially equivalent to K043271 (Inner Vision Biometrics Pty, Ltd., 2005) and 1 other predicate after an 87-day review. Its family tree reaches back 4 generations to 1994.
- Decided
- Jul 28, 2011
- Review
- 87 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K940172 (1994). 6 ancestors in all. No later device cites it as a predicate yet.
- 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 backK043271 R2-Mri Analysis SystemInner Vision Biometrics Pty, Ltd. · 2005
- This deviceK111222 Mri-Q SystemResonance Health Analysis Services Pty, Ltd. · 2011
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 | K043271 | R2-Mri Analysis System | Inner Vision Biometrics Pty, Ltd. | 2005 | — |
| 0 (this device) | K111222 | Mri-Q System | Resonance Health Analysis Services Pty, Ltd. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2008 | 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 |
|---|---|---|---|
| * | K043271 | R2-Mri Analysis SystemSummary page 2…f 85 510(k) Submission: MRI-Q System PREDICATE DEVICE(S): K043271: Resonance Health Analysis Services R2-MRI Analysis System… | 2005 |
| * | K073194 | Cmrtools and Plug-Ins Ventricular Tools & Thalassaemia ToolsSummary page 2…K043271: Resonance Health Analysis Services R2-MRI Analysis System K073 194 Cardiovascular Imaging Solutions Ltd. CMRtools and plug-in T… | 2008 |
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 17 years and passes through 4 companies; a new generation was cleared every 5.2 years on median.
- None of the 6 ancestors has a recall.
- 2 other devices also cite its predicate K043271.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 MRI-Q System is a software device that provides quantitative analysis of magnetic resonance image signal decay parameters in cardiac tissue. The device contains an image viewer for importing DICOM images, browsing through datasets and performing quantitative region of interest analysis. The software device has capability to measure the signal decay rate (R2*) and time (T 2 *) in heart tissue.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111222 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111222: Mri-Q System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111222
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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