510(k) · Cleared
ClearedCGS-30A Multislice Upgrade Kit for Aquilion CT Scanner, Model TSX-101A
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 Feb 15, 2002 as substantially equivalent to K982265 (Toshiba America Medical Systems, In.C, 1998) after a 10-day review. Its family tree reaches back 2 generations to 1990. 15 later devices descend from it.
- Decided
- Feb 15, 2002
- Review
- 10 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K903701 (1990). 15 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK903701 XpressToshiba America Medical Systems, In.C · 1990
- 1 generation backK982265 Aquilion CT Scanner, Model TSX-101AToshiba America Medical Systems, In.C · 1998 · Recalled
- This deviceK020385 CGS-30A Multislice Upgrade Kit for Aquilion CT Scanner, Model TSX-101AToshiba America Medical Systems, In.C · 2002
- Descendant · cites it directly · 14 of its ownK022050 CGS-31A Multislice Upgrade Kit for Aquilion CT Scanner. TSX-101A…Toshiba America Medical Systems, In.C · 2002
- Descendant · 2 generations on · 12 of its ownK050458 TSX-201A Aquilion LB CT ScannerToshiba America Medical Systems, In.C · 2005 · Recalled
- Descendant · 3 generations on · 4 of its ownK123500 Aquilion LB Triton V4.91Toshibamedical Systems Corporation · 2013
- Descendant · 3 generations on · 4 of its ownK111633 Aquilion LB Movement Base KitToshiba America Medical Systems, In.C · 2011
- Descendant · 4 generations on · 3 of its ownK134025 Aquilion One Vision Self-Propelled Scan Base Kit for Ivr-CTToshibamedical Systems Corporation · 2014
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K022050CGS-31A Multislice Upgrade Kit for Aquilion CT Scanner. TSX-101A (Aquilion Advance Multi)Toshiba America Medical Systems, In.C · 2002 · cites it directly14descendants
- K050458TSX-201A Aquilion LB CT ScannerToshiba America Medical Systems, In.C · 2005 · 2 generations on12descendants
- K123500Aquilion LB Triton V4.91Toshibamedical Systems Corporation · 2013 · 3 generations on4descendants
- K111633Aquilion LB Movement Base KitToshiba America Medical Systems, In.C · 2011 · 3 generations on4descendants
- K134025Aquilion One Vision Self-Propelled Scan Base Kit for Ivr-CTToshibamedical Systems Corporation · 2014 · 4 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K903701 | Xpress | Toshiba America Medical Systems, In.C | 1990 | — |
| −1 | K982265 | Aquilion CT Scanner, Model TSX-101A | Toshiba America Medical Systems, In.C | 1998 | 3 |
| 0 (this device) | K020385 | CGS-30A Multislice Upgrade Kit for Aquilion CT Scanner, Model TSX-101A | Toshiba America Medical Systems, In.C | 2002 | — |
| +1 | K022050 | CGS-31A Multislice Upgrade Kit for Aquilion CT Scanner. TSX-101A (Aquilion… | Toshiba America Medical Systems, In.C | 2002 | — |
| +2 | K050458 | TSX-201A Aquilion LB CT Scanner | Toshiba America Medical Systems, In.C | 2005 | 1 |
| +3 | K123500 | Aquilion LB Triton V4.91 | Toshibamedical Systems Corporation | 2013 | — |
| +3 | K111633 | Aquilion LB Movement Base Kit | Toshiba America Medical Systems, In.C | 2011 | — |
| +4 | K134025 | Aquilion One Vision Self-Propelled Scan Base Kit for Ivr-CT | Toshibamedical Systems Corporation | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 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? (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 |
|---|---|---|---|
| * | K982265 | Aquilion CT Scanner, Model TSX-101ASummary page 1…peed Ultra (K013651) Modification of cleared device Description of this Device: The Multislice kit is an upgrade to previously cleared Aquilion CT Scanner, TSX-101A; [K982265]. This upgrade will allow for the collection of eight axial slices in one scan. This is accomplished by employing multiple solid… | 1998 |
| * | — | CGS-22A Multislice Upgrade kit for Aquilion CT scanner Named without a submission number | |
| † | K013651 | Intergard Hemabridge Collagen Coated Vascular Prosthesis, Intergard Aortic Arch Collagen… | 2002 |
What descends from it? (15)
See all 152 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 12 years and passes through 1 company; a new generation was cleared every 7.8 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K022050 (Toshiba America Medical Systems, In.C, 2002) has gone furthest, with 14 descendants of its own.
- 2 other devices also cite its predicate K982265.
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.
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?
X-ray imaging of whole body - Computerized Tomography
Including:
Axial
Volumetric (Helical)
CT Fluoroscopy
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/K020385 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020385: CGS-30A Multislice Upgrade Kit for Aquilion CT Scanner, Model TSX-101A.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020385
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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