CT Coronary Artery Calcification Scoring (CACS) Option for Advantage Windows

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

510(k) Number

K982004 ↗

FDA Product Code

JAK

Device Class

Class II

Regulation

21 CFR Part 892.1750

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Generator, High Volt, X-Ray, Diag. MPX80

  Class I

  FDA 510(k) K802548 Active Cleared 2 Dec 1980

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• GE CT/T 8800 System

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• What is the CT Coronary Artery Calcification Scoring (CACS) Option for Advantage Windows used for?

  This software module is designed for post-processing and analyzing CT images to provide quantitative assessment of coronary artery calcification. By generating calcium scores from reconstructed CT scans, it helps radiologists and cardiologists evaluate atherosclerotic plaque burden and cardiovascular risk, supporting diagnosis and management of coronary artery disease.

• How is the CACS Option supplied and what systems does it integrate with?

  The CACS Option is supplied as part of the Advantage Windows software package and is intended for use on compatible CT imaging systems. It integrates directly with the Advantage Windows platform to enhance diagnostic workflows for cardiac imaging, ensuring seamless analysis of coronary artery calcification.

• Is the CACS Option for Advantage Windows sterile or single-use?

  The CACS Option is not a sterile device, as it functions as a digital analysis tool rather than a physical implant or consumable. It is intended for single-use analysis sessions within a clinical or diagnostic radiology setting, though the underlying Advantage Windows software may be reused across multiple scans.

• What regulatory clearance does the CACS Option hold?

  The device holds FDA 510(k) clearance under the reference number K982004. It is classified under product code JAK and adheres to regulatory standards for radiology software, having been determined substantially equivalent to a predicate device by the Radiology Advisory Committee.

• Can this software be used across different CT imaging systems?

  The CACS Option is specifically designed to operate on compatible CT imaging systems that integrate with the Advantage Windows platform. While it enhances workflows for cardiac imaging, compatibility depends on the system’s ability to support the Advantage Windows software environment.