510(k) · Cleared
Recalled · Class II · 2020Aquilion Prime SP (TSX-303B8) V10.2 with AiCE-i
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Canon Medical Systems Corporation · JAK System, X-Ray, Tomography, Computed
Cleared on Feb 21, 2020 as substantially equivalent to K172188 (Toshiba Medical Systems Coroporation, 2017) after a 142-day review. Its family tree reaches back 6 generations to 2010. 2 later devices descend from it. It has been recalled once.
- Decided
- Feb 21, 2020
- Review
- 142 days
- Class
- Class II
- Product code
- JAK
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 6 generations to K093891 (2010). 9 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK093891 Aquilion One Version 4.6 W/Dual Energy Scan System, Model TSX-301A/2Toshibamedical Systems Corporation · 2010 · Recalled
- 5 generations backK121553 Aquilion RXLToshibamedical Systems Corporation · 2012 · Recalled
- 4 generations backK151833 Aquilion Lightning (TSX-035A/2, V7.0)Toshibamedical Systems Corporation · 2015 · Recalled
- 3 generations backK153263 Aquilion Lightning, TSX-035A/4 and /5, V7.0Toshibamedical Systems Corporation · 2016
- 2 generations backK170019 Aquilion Lightning, TSX-036A/1, V8.4Toshibamedical Systems Corporation · 2017 · Recalled
- 1 generation backK172188 Aquilion Prime SP, TSX-303B/1, v8.4Toshiba Medical Systems Coroporation · 2017 · Recalled
- This deviceK192832 Aquilion Prime SP (TSX-303B8) V10.2 with AiCE-iCanon Medical Systems Corporation · 2020
- Descendant · cites it directly · 1 of its ownK203042 Aquilion Exceed LB (TSX-202A/3) V10.6 with AiCE-ICanon Medical Systems Corporation · 2020
- Descendant · 2 generations on · 0 of its ownK211828 Aquilion Exceed LBCanon Medical Systems Corporation · 2021
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K093891 | Aquilion One Version 4.6 W/Dual Energy Scan System, Model TSX-301A/2 | Toshibamedical Systems Corporation | 2010 | 1 |
| −5 | K121553 | Aquilion RXL | Toshibamedical Systems Corporation | 2012 | 1 |
| −4 | K151833 | Aquilion Lightning (TSX-035A/2, V7.0) | Toshibamedical Systems Corporation | 2015 | 1 |
| −3 | K153263 | Aquilion Lightning, TSX-035A/4 and /5, V7.0 | Toshibamedical Systems Corporation | 2016 | — |
| −2 | K170019 | Aquilion Lightning, TSX-036A/1, V8.4 | Toshibamedical Systems Corporation | 2017 | 1 |
| −1 | K172188 | Aquilion Prime SP, TSX-303B/1, v8.4 | Toshiba Medical Systems Coroporation | 2017 | 1 |
| 0 (this device) | K192832 | Aquilion Prime SP (TSX-303B8) V10.2 with AiCE-i | Canon Medical Systems Corporation | 2020 | — |
| +1 | K203042 | Aquilion Exceed LB (TSX-202A/3) V10.6 with AiCE-I | Canon Medical Systems Corporation | 2020 | — |
| +2 | K211828 | Aquilion Exceed LB | Canon Medical Systems Corporation | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 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 JAK? 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 JAK device
- #1 K230223 iCAC Devicescore 23.5 · 12 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.
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K203042 | Aquilion Exceed LB (TSX-202A/3) V10.6 with AiCE-I | 2020 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 9, 2020 | Class II | Z-0549-2021 | Software design | A software problem has been identified which could result in the CT Scanner not proceeding to the next actual scan even though automatic start of the next scan is specified. This could result in the CT scan failing resulting in rescanning… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 10 years and passes through 3 companies; a new generation was cleared every 1.7 years on median.
- 7 of the 9 ancestors have a recall of any class.
- Of its descendants, K203042 (Canon Medical Systems Corporation, 2020) has gone furthest, with 1 descendant of its own.
How does its category compare?
All JAK devicesJAK System, X-Ray, Tomography, Computed: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · JAK
27in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JAK
141in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JAK
17in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JAK
219in 2025
MAUDE reports naming product code JAK, 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 | 14 | 27 | 11 | 76 |
| 2008 | 26 | 42 | 16 | 120 |
| 2009 | 15 | 31 | 29 | 105 |
| 2010 | 7 | 92 | 51 | 119 |
| 2011 | 16 | 155 | 34 | 205 |
| 2012 | 28 | 121 | 23 | 192 |
| 2013 | 17 | 132 | 11 | 414 |
| 2014 | 30 | 200 | 10 | 308 |
| 2015 | 30 | 140 | 28 | 454 |
| 2016 | 25 | 129 | 44 | 365 |
| 2017 | 29 | 96 | 33 | 338 |
| 2018 | 24 | 114 | 10 | 543 |
| 2019 | 28 | 94 | 5 | 233 |
| 2020 | 30 | 112 | 8 | 177 |
| 2021 | 20 | 145 | 15 | 261 |
| 2022 | 30 | 131 | 9 | 199 |
| 2023 | 27 | 139 | 9 | 310 |
| 2024 | 26 | 141 | 20 | 212 |
| 2025 | 27 | 141 | 17 | 219 |
| 2026 | 21 | 167 | 23 | — |
What is it indicated for?
This device is indicated to acquire and display cross-sectional volumes of the whole body, to include the head.
The Aquilion Prime SP has the capability to provide volume sets. These volume sets can be used to perform specialized studies, using indicated software/hardware, by a trained and qualified physician.
AiCE (Advanced Intelligent Clear-IQ Engine) is a noise reduction algorithm that improves image quality and reduces image noise by employing Deep Convolutional Neural Network methods for abdomen, pelvis, lung, cardiac, extremities, head and inner ear applications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192832 · printed Nov 5, 2026
Cite this page
510(k) Report. “K192832: Aquilion Prime SP (TSX-303B8) V10.2 with AiCE-i.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K192832
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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