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CardIQ Xpress 2.0 with Snapshot Freeze Option CardIQ Xpress 2.0 Reveal

by GE Medical Systems SCS

510(k) K120910

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K120910↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Special NumberK120910 Date18 Jun 2012ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

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

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA Product Code
JAK
Device Class
Class II
Regulation
21 CFR Part 892.1750
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 20 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

CardIQ Xpress 2.0 with Snapshot Freeze Option is a post-processing imaging analysis application designed for cardiovascular imaging. It enables the display, reformatting, and analysis of 2D or 3D cardiac CT images to facilitate qualitative or quantitative assessment of heart anatomy and coronary arteries from single or multiple cardiac phase datasets. The software option integrates with GE Advantage Workstation and AW Server for enhanced workflow efficiency.

This device is supplied as a software option for use with GE CT systems, including the Snapshot Freeze feature for motion-blur reduction in coronary imaging. It is intended for use in radiology settings and requires compatibility with GE Advantage Workstation or AW Server platforms. The device holds FDA 510(k) clearance under Special Review and is authorized under the Medical Device Regulation (MDR). No sterility or single-use specifications are indicated.

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Questions

AI-generated answers, 20 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What types of cardiac imaging data can the CardIQ Xpress 2.0 software analyze, and how does it improve workflow efficiency?

    The CardIQ Xpress 2.0 software is designed to analyze 2D or 3D cardiac CT images, allowing radiologists to display, reformat, and assess heart anatomy and coronary arteries from either single or multi-phase datasets. It integrates with GE Advantage Workstation and AW Server, streamlining workflow by enabling seamless post-processing and analysis directly within these platforms. This integration reduces manual intervention and speeds up diagnostic assessments in radiology settings.

  • Does this software include features to reduce motion artifacts in coronary imaging, and if so, how?

    Yes, the CardIQ Xpress 2.0 includes the Snapshot Freeze Option, a feature specifically designed to minimize motion blur in coronary imaging. This helps improve image clarity and accuracy when evaluating coronary arteries, particularly in patients with cardiac motion challenges. The feature is part of the software’s post-processing capabilities, ensuring cleaner visualizations for diagnostic review.

  • Is this software compatible with all GE CT systems, or are there specific requirements for use?

    The CardIQ Xpress 2.0 is supplied as a software option for use with GE CT systems, but it requires compatibility with GE Advantage Workstation or AW Server platforms to function. While it integrates with GE’s imaging ecosystem, it is not a standalone device—its performance depends on the underlying hardware and software infrastructure already in place at the radiology facility.

  • How is the CardIQ Xpress 2.0 distributed, and does it come with any additional hardware or consumables?

    The CardIQ Xpress 2.0 is distributed as a software option, meaning it is not sold as a physical device but rather as an upgrade or add-on to existing GE Advantage Workstation or AW Server systems. Since it is purely software-based, no additional hardware or consumables (like disposables) are required. Installation and activation depend on the facility’s existing infrastructure and licensing agreements with GE Medical Systems.

  • What regulatory pathways does this software follow, and how does that affect its adoption in clinical settings?

    The CardIQ Xpress 2.0 holds FDA 510(k) clearance under Special Review (K120910) and is authorized under the Medical Device Regulation (MDR). This means it has undergone premarket review to demonstrate substantial equivalence to a predicate device, ensuring it meets safety and performance standards for clinical use in radiology settings. Facilities adopting it can rely on these regulatory clearances to confirm its compliance with applicable guidelines.