CGS-30A Multislice Upgrade Kit for Aquilion CT Scanner, Model TSX-101A

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K020385 ↗

FDA Product Code

JAK

Device Class

Class II

Regulation

21 CFR Part 892.1750

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

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See all devices from Toshiba America Medical Systems, In.C →

• What clinical setting is the CGS-30A Multislice Upgrade Kit designed for, and how does it improve imaging performance?

  The CGS-30A Multislice Upgrade Kit is designed specifically for clinical radiology settings where the Aquilion CT Scanner, Model TSX-101A, is already in use. It enhances imaging performance by enabling the acquisition of eight axial slices per rotation using multiple solid-state detectors. This upgrade improves imaging resolution and efficiency, allowing for faster and more detailed cross-sectional radiography, which can benefit diagnostic accuracy and workflow in radiology departments.

• Is the CGS-30A upgrade kit reusable or single-use, and what are the sterility and installation requirements?

  The CGS-30A Multislice Upgrade Kit is non-sterile and reusable, meaning it is intended for repeated use in clinical environments after proper cleaning and maintenance. Since it requires installation by trained personnel, facilities must ensure technicians with the appropriate expertise handle the upgrade to maintain functionality and safety. The manufacturer’s guidelines for storage and handling must also be followed to preserve performance.

• How is this upgrade kit regulated, and what does the FDA clearance (K020385) under product code JAK indicate?

  The CGS-30A upgrade kit holds FDA 510(k) clearance (K020385) under product code JAK, which means it has been determined to be substantially equivalent to a legally marketed device in the U.S. This clearance was reviewed by the FDA’s Radiology (RA) Advisory Committee and granted under a traditional 510(k) pathway. The clearance does not imply clinical indications but confirms the device meets regulatory standards for safety and effectiveness as an upgrade for the Aquilion CT Scanner, Model TSX-101A.

• What type of technical support or documentation is available for facilities considering this upgrade?

  While the provided data does not specify support details, the upgrade kit’s FDA clearance and manufacturer origin (Toshiba America Medical Systems) imply that comprehensive technical documentation, installation instructions, and post-sale support are available through Toshiba. Facilities should contact Toshiba’s customer service (e.g., via the provided contact, Paul Biggins) for access to training materials, maintenance guidelines, and any additional resources required for proper implementation and compliance.