510(k) · Cleared
ClearedAquilion LB Movement Base Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Toshiba America Medical Systems, In.C · JAK System, X-Ray, Tomography, Computed
Cleared on Aug 25, 2011 as substantially equivalent to K050458 (Toshiba America Medical Systems, In.C, 2005) after a 73-day review. Its family tree reaches back 5 generations to 1990. 4 later devices descend from it.
- Decided
- Aug 25, 2011
- Review
- 73 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K903701 (1990). 4 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK903701 XpressToshiba America Medical Systems, In.C · 1990
- 4 generations backK982265 Aquilion CT Scanner, Model TSX-101AToshiba America Medical Systems, In.C · 1998 · Recalled
- 3 generations backK020385 CGS-30A Multislice Upgrade Kit for Aquilion CT Scanner, Model TSX-101AToshiba America Medical Systems, In.C · 2002
- 2 generations backK022050 CGS-31A Multislice Upgrade Kit for Aquilion CT Scanner. TSX-101A…Toshiba America Medical Systems, In.C · 2002
- 1 generation backK050458 TSX-201A Aquilion LB CT ScannerToshiba America Medical Systems, In.C · 2005 · Recalled
- This deviceK111633 Aquilion LB Movement Base KitToshiba America Medical Systems, In.C · 2011
- Descendant · cites it directly · 3 of its ownK134025 Aquilion One Vision Self-Propelled Scan Base Kit for Ivr-CTToshibamedical Systems Corporation · 2014
- Descendant · 2 generations on · 2 of its ownK143223 CGBA-032A, Aquilion PRIME Self-Propelled Scan Base Kit for IVR-CTToshibamedical Systems Corporation · 2015
- Descendant · 3 generations on · 1 of its ownK182223 Aquilion ONE Self-Propelled Scan Base Kit for IVR-CT, CGBA-034ACanon Medical Systems, USA · 2018
- Descendant · 4 generations on · 0 of its ownK251645 Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B…Canon Medical Systems Corporation · 2025
Most influential descendants
Showing 4 of 4 · See all- K134025Aquilion One Vision Self-Propelled Scan Base Kit for Ivr-CTToshibamedical Systems Corporation · 2014 · cites it directly3descendants
- K143223CGBA-032A, Aquilion PRIME Self-Propelled Scan Base Kit for IVR-CTToshibamedical Systems Corporation · 2015 · 2 generations on2descendants
- K182223Aquilion ONE Self-Propelled Scan Base Kit for IVR-CT, CGBA-034ACanon Medical Systems, USA · 2018 · 3 generations on1descendant
- K251645Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B, INFX-8000C/S, V9.6…Canon Medical Systems Corporation · 2025 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K903701 | Xpress | Toshiba America Medical Systems, In.C | 1990 | — |
| −4 | K982265 | Aquilion CT Scanner, Model TSX-101A | Toshiba America Medical Systems, In.C | 1998 | 3 |
| −3 | K020385 | CGS-30A Multislice Upgrade Kit for Aquilion CT Scanner, Model TSX-101A | Toshiba America Medical Systems, In.C | 2002 | — |
| −2 | K022050 | CGS-31A Multislice Upgrade Kit for Aquilion CT Scanner. TSX-101A (Aquilion… | Toshiba America Medical Systems, In.C | 2002 | — |
| −1 | K050458 | TSX-201A Aquilion LB CT Scanner | Toshiba America Medical Systems, In.C | 2005 | 1 |
| 0 (this device) | K111633 | Aquilion LB Movement Base Kit | Toshiba America Medical Systems, In.C | 2011 | — |
| +1 | K134025 | Aquilion One Vision Self-Propelled Scan Base Kit for Ivr-CT | Toshibamedical Systems Corporation | 2014 | — |
| +2 | K143223 | CGBA-032A, Aquilion PRIME Self-Propelled Scan Base Kit for IVR-CT | Toshibamedical Systems Corporation | 2015 | — |
| +3 | K182223 | Aquilion ONE Self-Propelled Scan Base Kit for IVR-CT, CGBA-034A | Canon Medical Systems, USA | 2018 | — |
| +4 | K251645 | Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B… | Canon Medical Systems Corporation | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2025 | 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K050458 | TSX-201A Aquilion LB CT ScannerSummary page 1…-ray system 9. PERFORMANCE STANDARD: 21 CFR Subchapter J, Federal Diagnostic X-ray Equipment Standard 10. PREDICATE DEVICE: TSX-201A, Aquilion LB CT Scanner (K050458) 11. REASON FOR SUBMISSION: Modification of a cleared device 12. DEVI CE DESCRIPTION: This device is an optional kit… | 2005 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K134025 | Aquilion One Vision Self-Propelled Scan Base Kit for Ivr-CT | 2014 | 3 |
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 21 years and passes through 1 company; a new generation was cleared every 3.5 years on median.
- 2 of the 5 ancestors have a recall of any class.
- Of its descendants, K134025 (Toshibamedical Systems Corporation, 2014) has gone furthest, with 3 descendants of its own.
- 3 other devices also cite its predicate K050458.
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. 2011, 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?
Optional movable gantry base unit for use with the Aquilion LB CT Scanner to support the longitudinal movement and allow the acquisition of images in the z-direction (Z-axis).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111633 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111633: Aquilion LB Movement Base Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111633
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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