510(k) · Cleared
Recalled · Class II · 2019Aquilion Prime SP, TSX-303B/1, v8.4
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Toshiba Medical Systems Coroporation · JAK System, X-Ray, Tomography, Computed
Cleared on Oct 6, 2017 as substantially equivalent to K141741 (Toshibamedical Systems Corporation, 2014) and 1 other predicate after a 78-day review. Its family tree reaches back 5 generations to 2010. 3 later devices descend from it. It has been recalled once.
- Decided
- Oct 6, 2017
- Review
- 78 days
- Class
- Class II
- Product code
- JAK
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 5 generations to K093891 (2010). 8 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK093891 Aquilion One Version 4.6 W/Dual Energy Scan System, Model TSX-301A/2Toshibamedical Systems Corporation · 2010 · Recalled
- 4 generations backK121553 Aquilion RXLToshibamedical Systems Corporation · 2012 · Recalled
- 3 generations backK151833 Aquilion Lightning (TSX-035A/2, V7.0)Toshibamedical Systems Corporation · 2015 · Recalled
- 2 generations backK153263 Aquilion Lightning, TSX-035A/4 and /5, V7.0Toshibamedical Systems Corporation · 2016
- 1 generation backK170019 Aquilion Lightning, TSX-036A/1, V8.4Toshibamedical Systems Corporation · 2017 · Recalled
- This deviceK172188 Aquilion Prime SP, TSX-303B/1, v8.4Toshiba Medical Systems Coroporation · 2017
- Descendant · cites it directly · 2 of its ownK192832 Aquilion Prime SP (TSX-303B8) V10.2 with AiCE-iCanon Medical Systems Corporation · 2020 · Recalled
- Descendant · 2 generations on · 1 of its ownK203042 Aquilion Exceed LB (TSX-202A/3) V10.6 with AiCE-ICanon Medical Systems Corporation · 2020
- Descendant · 3 generations on · 0 of its ownK211828 Aquilion Exceed LBCanon Medical Systems Corporation · 2021
Most influential descendants
Showing 3 of 3 · See all- K192832Aquilion Prime SP (TSX-303B8) V10.2 with AiCE-iCanon Medical Systems Corporation · 2020 · cites it directly2descendants
- K203042Aquilion Exceed LB (TSX-202A/3) V10.6 with AiCE-ICanon Medical Systems Corporation · 2020 · 2 generations on1descendant
- K211828Aquilion Exceed LBCanon Medical Systems Corporation · 2021 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K093891 | Aquilion One Version 4.6 W/Dual Energy Scan System, Model TSX-301A/2 | Toshibamedical Systems Corporation | 2010 | 1 |
| −4 | K121553 | Aquilion RXL | Toshibamedical Systems Corporation | 2012 | 1 |
| −3 | K151833 | Aquilion Lightning (TSX-035A/2, V7.0) | Toshibamedical Systems Corporation | 2015 | 1 |
| −2 | K153263 | Aquilion Lightning, TSX-035A/4 and /5, V7.0 | Toshibamedical Systems Corporation | 2016 | — |
| −1 | K170019 | Aquilion Lightning, TSX-036A/1, V8.4 | Toshibamedical Systems Corporation | 2017 | 1 |
| 0 (this device) | K172188 | Aquilion Prime SP, TSX-303B/1, v8.4 | Toshiba Medical Systems Coroporation | 2017 | — |
| +1 | K192832 | Aquilion Prime SP (TSX-303B8) V10.2 with AiCE-i | Canon Medical Systems Corporation | 2020 | 1 |
| +2 | K203042 | Aquilion Exceed LB (TSX-202A/3) V10.6 with AiCE-I | Canon Medical Systems Corporation | 2020 | — |
| +3 | 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 | 2 | 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? (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 |
|---|---|---|---|
| * | K141741 | Aquilion Prime, V6.00Summary page 5…ber Clearance Date Aquilion PRIME, Toshiba America TSX‐303A/A, /B and /F, v6.00 K141741 November 11, 2014 Medical Systems (Primary Predicate Device) Aq… | 2014 |
| * | K170019 | Aquilion Lightning, TSX-036A/1, V8.4Summary page 5…dical Systems (Primary Predicate Device) Aquilion Lightning SP Toshiba America K170019 February 2, 2017 TSX‐036A/1, v8.4 Medical Systems 12. REASON FOR SUBMISSION: Modificat… | 2017 |
| † | K142465 | Aquilion ONE Vision, v7.0 | 2015 |
| † | K133324 | Suresubtraction Lung | 2014 |
| † | K170177 | Aquilion ONE (TSX-305A/3) V8.3 with FIRST 2.1 | 2017 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K192832 | Aquilion Prime SP (TSX-303B8) V10.2 with AiCE-i | 2020 | 2 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 25, 2019 | Class II | Z-1724-2020 | Software design | Scanning may be interrupted due to an error during execution of the eXam Plan and the system is unable to be shut down normally, resulting in the need to forcibly turn the system power off and reboot. Loss of the acquired raw data would… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 7 years and passes through 2 companies; a new generation was cleared every 10 months on median.
- 6 of the 8 ancestors have a recall of any class.
- Of its descendants, K192832 (Canon Medical Systems Corporation, 2020) has gone furthest, with 2 descendants of its own.
- 3 other devices also cite its predicate K141741.
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. 2017, 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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K172188 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172188: Aquilion Prime SP, TSX-303B/1, v8.4.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172188
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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