510(k) · Cleared
ClearedCVI42
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Circle Cardiovascular Imaging, Inc. · LLZ System, Image Processing, Radiological
Cleared on Aug 22, 2014 after a 79-day review. The FDA summary names its predicate without a number. 12 later devices descend from it.
- Decided
- Aug 22, 2014
- Review
- 79 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 0
12 later devices descend from it, 4 citing it directly.
- This deviceK141480 CVI42Circle Cardiovascular Imaging, Inc. · 2014
- Descendant · cites it directly · 7 of its ownK213998 cvi42 Auto Imaging Software ApplicationCircle Cardiovascular Imaging, Inc. · 2022
- Descendant · 2 generations on · 1 of its ownK243038 Salix CentralArtrya Limited · 2025
- Descendant · cites it directly · 1 of its ownK222854 iTFlowCardio Flow Design, Inc. · 2023
- Descendant · cites it directly · 1 of its ownK212565 CoverScan v1Perspectum, Ltd. · 2022
- Descendant · 2 generations on · 0 of its ownK251027 cvi42 Coronary Plaque Software ApplicationCircle Cardiovascular Imaging, Inc. · 2025
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K213998cvi42 Auto Imaging Software ApplicationCircle Cardiovascular Imaging, Inc. · 2022 · cites it directly7descendants
- K243038Salix CentralArtrya Limited · 2025 · 2 generations on1descendant
- K222854iTFlowCardio Flow Design, Inc. · 2023 · cites it directly1descendant
- K212565CoverScan v1Perspectum, Ltd. · 2022 · cites it directly1descendant
- K251027cvi42 Coronary Plaque Software ApplicationCircle Cardiovascular Imaging, Inc. · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K141480 | CVI42 | Circle Cardiovascular Imaging, Inc. | 2014 | — |
| +1 | K213998 | cvi42 Auto Imaging Software Application | Circle Cardiovascular Imaging, Inc. | 2022 | — |
| +2 | K243038 | Salix Central | Artrya Limited | 2025 | — |
| +1 | K222854 | iTFlow | Cardio Flow Design, Inc. | 2023 | — |
| +1 | K212565 | CoverScan v1 | Perspectum, Ltd. | 2022 | — |
| +2 | K251027 | cvi42 Coronary Plaque Software Application | Circle Cardiovascular Imaging, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 4 | 0 |
| 2025 | 4 | 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? (1)
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 |
|---|---|---|---|
| * | — | iNtuition Named without a submission number |
What descends from it? (12)
See all 124 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, K213998 (Circle Cardiovascular Imaging, Inc., 2022) has gone furthest, with 7 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. 2014, 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?
Cvi42 vascular analysis add-on is an image analysis software package add-on for evaluating CT and MR images of blood vessels. Combining digital image processing and visualization tools such as multiplaner reconstruction (MPR), thin/think maximum intensity projection (MIP) thin and think, inverted MIP thin and think, volume rendering technique (VRT), curved planner reformation, processing tools such as bone removal (based on both single energy and dual…
Read the full statement (180 words)
Cvi42 vascular analysis add-on is an image analysis software package add-on for evaluating CT and MR images of blood vessels. Combining digital image processing and visualization tools such as multiplaner reconstruction (MPR), thin/think maximum intensity projection (MIP) thin and think, inverted MIP thin and think, volume rendering technique (VRT), curved planner reformation, processing tools such as bone removal (based on both single energy and dual energy) table removal and evaluation tools (vessel centerline calculation, lumen calculation, stenosis calculation) and reporting tools (lesion location, lesion characteristics) and key images), the software package is designed to support the physician in conforming the presence or absence of physician identified lesion in blood vessels and evaluation, documentation and follow up of any such lesions.
It shall be used by qualified medical professionals, experienced in examining and evaluating cardiovascular CT or MR images, for the purpose of obtaining diagnostic information as part of a comprehensive diagnostic decision-making process. cvi42 is a software application that can be used as a stand-alone product or in a networked environment.
The target population for the cvi42 is not restricted.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141480 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141480: CVI42.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141480
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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