510(k) · Cleared
ClearedCardioct
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shina Systems, Ltd. · LLZ System, Image Processing, Radiological
Cleared on Mar 9, 2007 after a 44-day review. The FDA summary names its predicate without a number. 66 later devices descend from it.
- Decided
- Mar 9, 2007
- Review
- 44 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 0
66 later devices descend from it, 4 citing it directly.
- This deviceK070226 CardioctShina Systems, Ltd. · 2007
- Descendant · cites it directly · 41 of its ownK093269 Procedure Rehearsal StudioSimbionix, Ltd. · 2010
- Descendant · 2 generations on · 40 of its ownK112387 Procedure Rehearsal Studio (TM)Simbionix, Ltd. · 2011
- Descendant · 3 generations on · 37 of its ownK123023 Surgery Rehearsal PlatformSurgical Theater, LLC · 2013
- Descendant · 4 generations on · 27 of its ownK142107 Echo True 3D ViewerEchopixel, Inc. · 2015 · Recalled
- Descendant · cites it directly · 19 of its ownK092747 Philips Comprehensive Cardiac Analysis (Cca) - Plaque Assessment ToolPhilips Medical Systems (Cleveland), Inc. · 2009
Showing 5 of 66 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 66 · See all- K093269Procedure Rehearsal StudioSimbionix, Ltd. · 2010 · cites it directly41descendants
- K112387Procedure Rehearsal Studio (TM)Simbionix, Ltd. · 2011 · 2 generations on40descendants
- K123023Surgery Rehearsal PlatformSurgical Theater, LLC · 2013 · 3 generations on37descendants
- K142107Echo True 3D ViewerEchopixel, Inc. · 2015 · 4 generations on27descendants
- K092747Philips Comprehensive Cardiac Analysis (Cca) - Plaque Assessment ToolPhilips Medical Systems (Cleveland), Inc. · 2009 · cites it directly19descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K070226 | Cardioct | Shina Systems, Ltd. | 2007 | — |
| +1 | K093269 | Procedure Rehearsal Studio | Simbionix, Ltd. | 2010 | — |
| +2 | K112387 | Procedure Rehearsal Studio (TM) | Simbionix, Ltd. | 2011 | — |
| +3 | K123023 | Surgery Rehearsal Platform | Surgical Theater, LLC | 2013 | — |
| +4 | K142107 | Echo True 3D Viewer | Echopixel, Inc. | 2015 | 1 |
| +1 | K092747 | Philips Comprehensive Cardiac Analysis (Cca) - Plaque Assessment Tool | Philips Medical Systems (Cleveland), Inc. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 3 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 3 | 0 |
| 2019 | 3 | 0 |
| 2020 | 3 | 0 |
| 2021 | 2 | 0 |
| 2022 | 6 | 0 |
| 2023 | 7 | 0 |
| 2024 | 4 | 0 |
| 2025 | 12 | 0 |
| 2026 | 9 | 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 |
|---|---|---|---|
| * | — | Comprehensive Cardiac Analysis (CCA) module of the "Brilliance CT, Private Practice CV… Named without a submission number |
What descends from it? (66)
See all 664 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, K093269 (Simbionix, Ltd., 2010) has gone furthest, with 41 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. 2007, 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 system, which is comprised of diagnostic reading software, is intended for use by cardiologists and radiologists as an interactive tool for viewing and analyzing cardiac CT data for determining the presence and extent of coronary obstructive disease.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070226 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070226: Cardioct.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070226
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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