510(k) · Cleared
ClearedCardio Vue Quantitative Analysis (CVQ)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mri Cardiac Services, Incorporated · LLZ System, Image Processing, Radiological
Cleared on Jan 5, 2009 as substantially equivalent to K994283 (Medis Medical Imaging Systems BV, 2000) and 1 other predicate after a 125-day review. Its family tree reaches back 3 generations to 1994.
- Decided
- Jan 5, 2009
- Review
- 125 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K940172 (1994). 5 ancestors in all, the oldest K924605 (1993). No later device cites it as a predicate yet.
- Root · 3 generations backK940172 Cardiovascular Measurement System-CMSMedis Medical Imaging Systems, Inc. · 1994
- 2 generations backK993765 Quantitative Analysis of Left Ventricular Angiograms (QLV)Medis Medical Imaging Systems BV · 1999
- 1 generation backK994283 Mri- Magnetic Resonance Analytical Software SystemMedis Medical Imaging Systems BV · 2000
- This deviceK082526 Cardio Vue Quantitative Analysis (CVQ)Mri Cardiac Services, Incorporated · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K940172 | Cardiovascular Measurement System-CMS | Medis Medical Imaging Systems, Inc. | 1994 | — |
| −2 | K993765 | Quantitative Analysis of Left Ventricular Angiograms (QLV) | Medis Medical Imaging Systems BV | 1999 | — |
| −1 | K994283 | Mri- Magnetic Resonance Analytical Software System | Medis Medical Imaging Systems BV | 2000 | — |
| 0 (this device) | K082526 | Cardio Vue Quantitative Analysis (CVQ) | Mri Cardiac Services, Incorporated | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 2000 | 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 |
|---|---|---|---|
| * | K994283 | Mri- Magnetic Resonance Analytical Software SystemSummary page 3…y on the market. MRI Cardiac Services, Inc considers the features of the CVQ to be substantially equivalent to the subset of features in common with the MRI-Mass (510(k) 994283) and MRI-Flow (510(k) 994282) and that the subset of features is not effected by the operation of CardioVue TM (K060840) of which… | 2000 |
| * | K994282 | Mri- Flow Analytical Software PackageSummary page 3…Services, Inc considers the features of the CVQ to be substantially equivalent to the subset of features in common with the MRI-Mass (510(k) 994283) and MRI-Flow (510(k) 994282) and that the subset of features is not effected by the operation of CardioVue TM (K060840) of which it is an integrated module.… | 2000 |
| † | K060840 | SVIEW | 2006 |
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 15 years and passes through 3 companies; a new generation was cleared every 5.2 years on median.
- None of the 5 ancestors has a recall.
- 7 other devices also cite its predicate K994283.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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?
CardioVue Quantitative AnalysisTM is an integrated software component of the CardioVue (K060840) medical image management device that analyzes DICOM-compliant cardiovascular images acquired from MRI scanners and produces reports. CardioVue Quantitative Analysis TM assists qualified cardiologist, radiologist or other licensed professional healthcare practitioners in making their diagnosis by performing functional and blood flow analysis and in reporting…
Read the full statement (101 words)
CardioVue Quantitative AnalysisTM is an integrated software component of the CardioVue (K060840) medical image management device that analyzes DICOM-compliant cardiovascular images acquired from MRI scanners and produces reports. CardioVue Quantitative Analysis TM assists qualified cardiologist, radiologist or other licensed professional healthcare practitioners in making their diagnosis by performing functional and blood flow analysis and in reporting their patient study findings. It is a support tool that provides relevant clinical data as a resource to the clinician and is not intended to be a source of medical advice or to determine or recommend a course of action or treatment for a patient.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082526 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082526: Cardio Vue Quantitative Analysis (CVQ).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082526
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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