510(k) · Cleared
ClearedImagenmd with Imagenq
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardiovascular Imaging Technologies, LLC · LLZ System, Image Processing, Radiological
Cleared on Apr 9, 2008 after a 22-day review. The FDA summary names its predicate without a number. 23 later devices descend from it.
- Decided
- Apr 9, 2008
- Review
- 22 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 0
23 later devices descend from it, 3 citing it directly.
- This deviceK080770 Imagenmd with ImagenqCardiovascular Imaging Technologies, LLC · 2008
- Descendant · cites it directly · 20 of its ownK083327 Syngocirculation Dynamicpet, Version 1.0Siemens Medical Solutions USA, Inc. · 2009
- Descendant · 2 generations on · 12 of its ownK101279 CORRIDOR4DM V2010 Model: V2010Invia · 2010
- Descendant · cites it directly · 9 of its ownK113754 CFR QuantUniversity of Texas Medical School AT Houston · 2012
- Descendant · 2 generations on · 6 of its ownK143664 HeartSeeUniversity of Texas Medical School AT Houston · 2015
- Descendant · 2 generations on · 6 of its ownK110494 Syngo MBFSiemens Medical Solutions USA, Inc. · 2011
Showing 5 of 23 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 23 · See all- K083327Syngocirculation Dynamicpet, Version 1.0Siemens Medical Solutions USA, Inc. · 2009 · cites it directly20descendants
- K101279CORRIDOR4DM V2010 Model: V2010Invia · 2010 · 2 generations on12descendants
- K113754CFR QuantUniversity of Texas Medical School AT Houston · 2012 · cites it directly9descendants
- K143664HeartSeeUniversity of Texas Medical School AT Houston · 2015 · 2 generations on6descendants
- K110494Syngo MBFSiemens Medical Solutions USA, Inc. · 2011 · 2 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K080770 | Imagenmd with Imagenq | Cardiovascular Imaging Technologies, LLC | 2008 | — |
| +1 | K083327 | Syngocirculation Dynamicpet, Version 1.0 | Siemens Medical Solutions USA, Inc. | 2009 | — |
| +2 | K101279 | CORRIDOR4DM V2010 Model: V2010 | Invia | 2010 | — |
| +1 | K113754 | CFR Quant | University of Texas Medical School AT Houston | 2012 | — |
| +2 | K143664 | HeartSee | University of Texas Medical School AT Houston | 2015 | — |
| +2 | K110494 | Syngo MBF | Siemens Medical Solutions USA, Inc. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2023 | 3 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 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 21.6 · 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 |
|---|---|---|---|
| * | — | Ecat Lso Pet/CT 16 Named without a submission number | |
| * | — | EMORY Cardiac Toolbox Named without a submission number |
What descends from it? (23)
See all 233 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K083327 (Siemens Medical Solutions USA, Inc., 2009) has gone furthest, with 20 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. 2008, 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 ImagenMDT M with ImagenQ TM system is software that allows the user to visualize raw PET and/or PET/CT data, assist in evaluating the quality of PET scans, and perform quantitative measurements of tracer uptake to aid in the interpretation of myocardial perfusion PET images.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080770 · printed Nov 3, 2026
Cite this page
510(k) Report. “K080770: Imagenmd with Imagenq.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080770
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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