510(k) · Cleared
ClearedSelf-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B, INFX-8000C/S, V9.6 with Calculated DAP
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 Sep 26, 2025 as substantially equivalent to K182223 (Canon Medical Systems, USA, 2018) and 2 other predicates after a 120-day review. Its family tree reaches back 20 generations to 1991.
- Decided
- Sep 26, 2025
- Review
- 120 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 20 generations to K913770 (1991). 208 ancestors in all, the oldest K871859 (1987). No later device cites it as a predicate yet.
- Root · 20 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 16 generations between
- 3 generations backK213504 Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System…Canon Medical Systems Corporation · 2022
- 2 generations backK232835 Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction SystemCanon Medical Systems Corporation · 2024
- 1 generation backK242403 Aquilion ONE (TSX-308A/3) V1.5Canon Medical Systems Corporation · 2024
- This deviceK251645 Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B…Canon Medical Systems Corporation · 2025
Show all 20 generations
- Root · 20 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 19 generations backK960613 GE Advantage Windows Review WorkstationGE Medical Systems · 1996
- 18 generations backK020483 Advantage Workstation 4.1GE Medical Systems · 2002 · Recalled
- 17 generations backK023003 Imagechecker-CT WorkstationR2 Technology, Inc. · 2002
- 16 generations backK032748 VITREA2, Version 3.4 Medical Image Processing SoftwareVital Images, Inc. · 2003 · Recalled
- 15 generations backK040305 VITREA2 Version 3.5Vital Images, Inc. · 2004
- 14 generations backK043333 VITREA2, Version 3.7 Medical Image Processing SystemVital Images, Inc. · 2004 · Recalled
- 13 generations backK052632 VITREA2 Version 3.8 Medical Image Processing SoftwareVital Images, Inc. · 2005 · Recalled
- 12 generations backK061624 Vitrea, Version 3.9Vital Images, Inc. · 2006 · Recalled
- 11 generations backK071331 Vitrea Version 4.0Vital Images, Inc. · 2007 · Recalled
- 10 generations backK073156 Qplaque MRMedis Medical Imaging Systems BV · 2008
- 9 generations backK120636 Synapse 3D Cardiac ToolsFujifilm Medical System U.S.A., Inc. · 2012
- 8 generations backK171222 Vitrea Software Toshiba Package; VSTP-001AToshibamedical Systems Corporation · 2017
- 7 generations backK173088 Vitrea Software Toshiba Package VSTP-001AToshibamedical Systems Corporation · 2018
- 6 generations backK183013 Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation · 2018
- 5 generations backK192923 Vitrea Software PackageCanon Medical Systems Corporation · 2020
- 4 generations backK203312 Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation · 2021
- 3 generations backK213504 Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System…Canon Medical Systems Corporation · 2022
- 2 generations backK232835 Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction SystemCanon Medical Systems Corporation · 2024
- 1 generation backK242403 Aquilion ONE (TSX-308A/3) V1.5Canon Medical Systems Corporation · 2024
- This deviceK251645 Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B…Canon Medical Systems Corporation · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −20 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −19 | K960613 | GE Advantage Windows Review Workstation | GE Medical Systems | 1996 | — |
| −18 | K020483 | Advantage Workstation 4.1 | GE Medical Systems | 2002 | 2 |
| −17 | K023003 | Imagechecker-CT Workstation | R2 Technology, Inc. | 2002 | — |
| −16 | K032748 | VITREA2, Version 3.4 Medical Image Processing Software | Vital Images, Inc. | 2003 | 2 |
| −15 | K040305 | VITREA2 Version 3.5 | Vital Images, Inc. | 2004 | — |
| −14 | K043333 | VITREA2, Version 3.7 Medical Image Processing System | Vital Images, Inc. | 2004 | 1 |
| −13 | K052632 | VITREA2 Version 3.8 Medical Image Processing Software | Vital Images, Inc. | 2005 | 2 |
| −12 | K061624 | Vitrea, Version 3.9 | Vital Images, Inc. | 2006 | 1 |
| −11 | K071331 | Vitrea Version 4.0 | Vital Images, Inc. | 2007 | 1 |
| −10 | K073156 | Qplaque MR | Medis Medical Imaging Systems BV | 2008 | — |
| −9 | K120636 | Synapse 3D Cardiac Tools | Fujifilm Medical System U.S.A., Inc. | 2012 | — |
| −8 | K171222 | Vitrea Software Toshiba Package; VSTP-001A | Toshibamedical Systems Corporation | 2017 | — |
| −7 | K173088 | Vitrea Software Toshiba Package VSTP-001A | Toshibamedical Systems Corporation | 2018 | — |
| −6 | K183013 | Vitrea Software Package, VSTP-001A | Canon Medical Systems Corporation | 2018 | — |
| −5 | K192923 | Vitrea Software Package | Canon Medical Systems Corporation | 2020 | — |
| −4 | K203312 | Vitrea Software Package, VSTP-001A | Canon Medical Systems Corporation | 2021 | — |
| −3 | K213504 | Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software… | Canon Medical Systems Corporation | 2022 | — |
| −2 | K232835 | Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction System | Canon Medical Systems Corporation | 2024 | — |
| −1 | K242403 | Aquilion ONE (TSX-308A/3) V1.5 | Canon Medical Systems Corporation | 2024 | — |
| 0 (this device) | 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 |
|---|---|---|
| 1987 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 2 | 0 |
| 1991 | 4 | 0 |
| 1992 | 2 | 0 |
| 1993 | 4 | 0 |
| 1994 | 4 | 0 |
| 1995 | 7 | 0 |
| 1996 | 6 | 0 |
| 1997 | 6 | 0 |
| 1998 | 9 | 0 |
| 1999 | 5 | 0 |
| 2000 | 12 | 0 |
| 2001 | 17 | 0 |
| 2002 | 19 | 0 |
| 2003 | 15 | 0 |
| 2004 | 13 | 0 |
| 2005 | 10 | 0 |
| 2006 | 8 | 0 |
| 2007 | 4 | 0 |
| 2008 | 3 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 4 | 0 |
| 2012 | 5 | 0 |
| 2013 | 2 | 0 |
| 2014 | 3 | 0 |
| 2015 | 5 | 0 |
| 2016 | 3 | 0 |
| 2017 | 1 | 0 |
| 2018 | 3 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 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? (3)
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 |
|---|---|---|---|
| * | K182223 | Aquilion ONE Self-Propelled Scan Base Kit for IVR-CT, CGBA-034ASummary page 6…Medical 21 CFR September for IVR-CT, tomography JAK K182223 Systems 892.1750 14, 2018 CGBA-034A… | 2018 |
| * | K242403 | Aquilion ONE (TSX-308A/3) V1.5Summary page 6…Medical 21 CFR December V1.5 tomography JAK K242403 Systems 892.1750 23, 2024 (Secondary… | 2024 |
| * | K210900 | Alphenix, INFX-8000C/B, INFX-8000C/S, V9.2Summary page 7…INFX-8000C/S, V9.6 with Calculated INFX-8000C/S, V9.2 DAP (Modified as K210900) Gantry tilting Max. +/-30° Max. +/-28° Gantry movement High speed 130… | 2021 |
| † | K213504 | Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package… | 2022 |
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 34 years and passes through 8 companies; a new generation was cleared every 11 months on median.
- 68 of the 208 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?
The movable gantry base unit allows the Aquilion ONE (TSX-308A) system to be installed in the same procedure room as the INFX-8000C system, enabling coordinated clinical use within a shared workspace. This configuration provides longitudinal positioning along the z-axis for image acquisition. This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography configuration. The system is indicated for use in…
Read the full statement (156 words)
The movable gantry base unit allows the Aquilion ONE (TSX-308A) system to be installed in the same procedure room as the INFX-8000C system, enabling coordinated clinical use within a shared workspace. This configuration provides longitudinal positioning along the z-axis for image acquisition.
This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography configuration. The system is indicated for use in diagnostic and angiographic procedures for blood vessels in the heart, brain, abdomen and lower extremities. The Calculated Dose Area Product (DAP) feature provides an alternative method for determining dose metrics without the use of a physical area dosimeter. This function estimates the cumulative reference air kerma, reference air kerma rate, and cumulative dose area product based on system parameters, including X-ray exposure settings, beam hardening filter configuration, beam limiting device position, and region of interest (ROI) filter status. The calculation method is calibration-dependent, with accuracy contingent upon periodic calibration against reference measurements.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251645 · printed Nov 4, 2026
Cite this page
510(k) Report. “K251645: Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B, INFX-8000C/S, V9.6 with Calculated DAP.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K251645
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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