# K251645: Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B, INFX-8000C/S, V9.6 with Calculated DAP

- Pathway: 510(k) (Traditional)
- Applicant: Canon Medical Systems Corporation
- Decided: Sep 26, 2025 after 120 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 20 generations back to K913770 (1991). 208 ancestors in all.
No later device cites it as a predicate yet.
0 of 209 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182223: Aquilion ONE Self-Propelled Scan Base Kit for IVR-CT, CGBA-034A, Canon Medical Systems, USA (2018) Summary page 6.
- K242403: Aquilion ONE (TSX-308A/3) V1.5, Canon Medical Systems Corporation (2024) Summary page 6.
- K210900: Alphenix, INFX-8000C/B, INFX-8000C/S, V9.2, Canon Medical Systems Corporation (2021) Summary page 7.

## Indications for use
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.

Source page: https://510kreport.com/device/K251645
Methodology: https://510kreport.com/methodology