510(k) · Cleared
ClearedAquilion ONE Self-Propelled Scan Base Kit for IVR-CT, CGBA-034A
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Canon Medical Systems, USA · JAK System, X-Ray, Tomography, Computed
Cleared on Sep 14, 2018 as substantially equivalent to K143223 (Toshibamedical Systems Corporation, 2015) after a 29-day review. Its family tree reaches back 10 generations to 1989. 1 later device descends from it.
- Decided
- Sep 14, 2018
- Review
- 29 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K890348 (1989). 33 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 10 generations backK890348 LC, Cardiac Positioner #B5078AGeneral Electric Co. · 1989 · Recalled
- 6 generations between
- 3 generations backK113052 Infinix-CciToshiba America Medical Systems, In.C · 2011 · Recalled
- 2 generations backK134025 Aquilion One Vision Self-Propelled Scan Base Kit for Ivr-CTToshibamedical Systems Corporation · 2014
- 1 generation backK143223 CGBA-032A, Aquilion PRIME Self-Propelled Scan Base Kit for IVR-CTToshibamedical Systems Corporation · 2015
- This deviceK182223 Aquilion ONE Self-Propelled Scan Base Kit for IVR-CT, CGBA-034ACanon Medical Systems, USA · 2018
- Descendant · cites it directly · 0 of its ownK251645 Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B…Canon Medical Systems Corporation · 2025
Show all 10 generations
- Root · 10 generations backK890348 LC, Cardiac Positioner #B5078AGeneral Electric Co. · 1989 · Recalled
- 9 generations backK993037 LCV+ Version 2Ge Medical Systems, Inc. · 2000 · Recalled
- 8 generations backK022322 Innova and Innova 2000 SGe Medical Systems, Inc. · 2002 · Recalled
- 7 generations backK031637 Innova 3100GE Medical Systems · 2003 · Recalled
- 6 generations backK050489 Innova 2100Ge Medical Systems, LLC · 2005 · Recalled
- 5 generations backK052412 Innova 2100-IQ, Innova 3100, Innova 3100-IQ, Innova 4100, and Innova…GE Healthcare · 2005 · Recalled
- 4 generations backK081621 Infx-8000C (Infinix CC-I and VC-I)Toshiba America Medical Systems, In.C · 2008 · Recalled
- 3 generations backK113052 Infinix-CciToshiba America Medical Systems, In.C · 2011 · Recalled
- 2 generations backK134025 Aquilion One Vision Self-Propelled Scan Base Kit for Ivr-CTToshibamedical Systems Corporation · 2014
- 1 generation backK143223 CGBA-032A, Aquilion PRIME Self-Propelled Scan Base Kit for IVR-CTToshibamedical Systems Corporation · 2015
- This deviceK182223 Aquilion ONE Self-Propelled Scan Base Kit for IVR-CT, CGBA-034ACanon Medical Systems, USA · 2018
Most influential descendants
Showing 1 of 1 · See all- K251645Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B, INFX-8000C/S, V9.6…Canon Medical Systems Corporation · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K890348 | LC, Cardiac Positioner #B5078A | General Electric Co. | 1989 | 5 |
| −9 | K993037 | LCV+ Version 2 | Ge Medical Systems, Inc. | 2000 | 6 |
| −8 | K022322 | Innova and Innova 2000 S | Ge Medical Systems, Inc. | 2002 | 7 |
| −7 | K031637 | Innova 3100 | GE Medical Systems | 2003 | 25 |
| −6 | K050489 | Innova 2100 | Ge Medical Systems, LLC | 2005 | 27 |
| −5 | K052412 | Innova 2100-IQ, Innova 3100, Innova 3100-IQ, Innova 4100, and Innova 4100-IQ | GE Healthcare | 2005 | 50 |
| −4 | K081621 | Infx-8000C (Infinix CC-I and VC-I) | Toshiba America Medical Systems, In.C | 2008 | 1 |
| −3 | K113052 | Infinix-Cci | Toshiba America Medical Systems, In.C | 2011 | 1 |
| −2 | K134025 | Aquilion One Vision Self-Propelled Scan Base Kit for Ivr-CT | Toshibamedical Systems Corporation | 2014 | — |
| −1 | K143223 | CGBA-032A, Aquilion PRIME Self-Propelled Scan Base Kit for IVR-CT | Toshibamedical Systems Corporation | 2015 | — |
| 0 (this device) | K182223 | Aquilion ONE Self-Propelled Scan Base Kit for IVR-CT, CGBA-034A | Canon Medical Systems, USA | 2018 | — |
| +1 | K251645 | Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B… | Canon Medical Systems Corporation | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 3 | 0 |
| 1998 | 2 | 0 |
| 2001 | 2 | 0 |
| 2002 | 4 | 0 |
| 2003 | 1 | 0 |
| 2005 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K143223 | CGBA-032A, Aquilion PRIME Self-Propelled Scan Base Kit for IVR-CTSummary page 5…Computed Aquilion PRIME Medical 21 CFR Tomography JAK K143223 January 12, 2015 Self‐Propelled Scan Systems 892.1750 System Base… | 2015 |
| † | K170177 | Aquilion ONE (TSX-305A/3) V8.3 with FIRST 2.1 | 2017 |
| † | K181804 | Alphenix, INFX-8000C/B, V8.0 | 2018 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K251645 | Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B, INFX-8000C/S, V9.6… | 2025 | 0 |
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 29 years and passes through 8 companies; a new generation was cleared every 2.8 years on median.
- 22 of the 33 ancestors have a recall of any class.
- Of its descendants, K251645 (Canon Medical Systems Corporation, 2025) has gone furthest, with 0 descendants 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. 2018, 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 an Aquilion ONE (TSX-305A) system to support longitudinal movement and allow acquisition of images in the z-direction (z-axis).
Note: When installed with the movable gantry base unit, Aquilion ONE can be used with the INFX-8000C system in the same room.
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/K182223 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182223: Aquilion ONE Self-Propelled Scan Base Kit for IVR-CT, CGBA-034A.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K182223
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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