510(k) · Cleared
ClearedCT Scanner TSX-501R/1 V11.1
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 Jun 20, 2025 as substantially equivalent to K223726 (Canon Medical Systems Corporation, 2023) after a 232-day review. Its family tree reaches back 7 generations to 2012.
- Decided
- Jun 20, 2025
- Review
- 232 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K120710 (2012). No later device cites it as a predicate yet.
- Root · 7 generations backK120710 Aquilion PrimeToshibamedical Systems Corporation · 2012 · Recalled
- 6 generations backK130645 Aquilion Prime, V5.00Toshibamedical Systems Corporation · 2013
- 5 generations backK141741 Aquilion Prime, V6.00Toshibamedical Systems Corporation · 2014 · Recalled
- 4 generations backK173468 Aquilion Precision (TSX-304A/2) V8.6 with FIRST 3.0Toshibamedical Systems Corporation · 2018 · Recalled
- 3 generations backK182901 Aquilion Precision (TSX-304A/1 and /2) V8.8 with AiCECanon Medical Systems Corporation · 2019
- 2 generations backK220986 Aquilion Precision (TSX-304A/4) V10.10 with AiCECanon Medical Systems Corporation · 2022
- 1 generation backK223726 Aquilion Precision (TSX-304A/4) V10.14 with AiCECanon Medical Systems Corporation · 2023
- This deviceK243398 CT Scanner TSX-501R/1 V11.1Canon Medical Systems Corporation · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K120710 | Aquilion Prime | Toshibamedical Systems Corporation | 2012 | 2 |
| −6 | K130645 | Aquilion Prime, V5.00 | Toshibamedical Systems Corporation | 2013 | — |
| −5 | K141741 | Aquilion Prime, V6.00 | Toshibamedical Systems Corporation | 2014 | 2 |
| −4 | K173468 | Aquilion Precision (TSX-304A/2) V8.6 with FIRST 3.0 | Toshibamedical Systems Corporation | 2018 | 1 |
| −3 | K182901 | Aquilion Precision (TSX-304A/1 and /2) V8.8 with AiCE | Canon Medical Systems Corporation | 2019 | — |
| −2 | K220986 | Aquilion Precision (TSX-304A/4) V10.10 with AiCE | Canon Medical Systems Corporation | 2022 | — |
| −1 | K223726 | Aquilion Precision (TSX-304A/4) V10.14 with AiCE | Canon Medical Systems Corporation | 2023 | — |
| 0 (this device) | K243398 | CT Scanner TSX-501R/1 V11.1 | Canon Medical Systems Corporation | 2025 | — |
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?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 13 years and passes through 2 companies; a new generation was cleared every 1.5 years on median.
- 3 of the 7 ancestors have a recall of any class.
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. 2025, 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 (abdomen, pelvis, chest, extremities, and head) of adult patients.
TSX-501 R 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 as stated in the FDA summary.
https://510kreport.com/device/K243398 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243398: CT Scanner TSX-501R/1 V11.1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243398
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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