510(k) · Cleared
ClearedVitrea Software Package; VSTP-001A
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Canon Medical Systems Corporation · LLZ System, Image Processing, Radiological
Cleared on Mar 30, 2018 after a 53-day review. The FDA summary names no predicate by number. 11 later devices descend from it.
- Decided
- Mar 30, 2018
- Review
- 53 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 0
11 later devices descend from it, 2 citing it directly.
- This deviceK180323 Vitrea Software Package; VSTP-001ACanon Medical Systems Corporation · 2018
- Descendant · cites it directly · 9 of its ownK183013 Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation · 2018
- Descendant · 2 generations on · 8 of its ownK192923 Vitrea Software PackageCanon Medical Systems Corporation · 2020
- Descendant · 3 generations on · 7 of its ownK203312 Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation · 2021
- Descendant · 4 generations on · 6 of its ownK213504 Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System…Canon Medical Systems Corporation · 2022
- Descendant · 5 generations on · 3 of its ownK232835 Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction SystemCanon Medical Systems Corporation · 2024
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K183013Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation · 2018 · cites it directly9descendants
- K192923Vitrea Software PackageCanon Medical Systems Corporation · 2020 · 2 generations on8descendants
- K203312Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation · 2021 · 3 generations on7descendants
- K213504Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package…Canon Medical Systems Corporation · 2022 · 4 generations on6descendants
- K232835Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction SystemCanon Medical Systems Corporation · 2024 · 5 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K180323 | Vitrea Software Package; VSTP-001A | Canon Medical Systems Corporation | 2018 | — |
| +1 | K183013 | Vitrea Software Package, VSTP-001A | Canon Medical Systems Corporation | 2018 | — |
| +2 | K192923 | Vitrea Software Package | Canon Medical Systems Corporation | 2020 | — |
| +3 | K203312 | Vitrea Software Package, VSTP-001A | Canon Medical Systems Corporation | 2021 | — |
| +4 | K213504 | Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software… | Canon Medical Systems Corporation | 2022 | — |
| +5 | K232835 | Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction System | Canon Medical Systems Corporation | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 3 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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?
The FDA summary names no predicate by number.
What descends from it? (11)
See all 112 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, K183013 (Canon Medical Systems Corporation, 2018) has gone furthest, with 9 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. 2018, 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 | — |
https://510kreport.com/device/K180323 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180323: Vitrea Software Package; VSTP-001A.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180323
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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