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Revolution Maxima, Revolution Ace (K192686)

by Ge Hangwei Medical Systems Co., Ltd. EUDAMED510(k)

Active European Union and United States

510(k) K192686

Overview

The Revolution Maxima and Revolution Ace are computed tomography (CT) systems designed for high-speed, full-coverage imaging in radiology. These devices utilize a 40 mm detector to deliver 0.28 mm² spatial resolution, enabling rapid and high-quality scans for diverse clinical applications. Classified under the product code JAK, they fall under the category of X-ray tomography systems.

Supplied by GE Hangwei Medical Systems Co., Ltd., these devices are intended for use in radiology settings and have received FDA 510(k) clearance under the Special classification (K192686). They are not explicitly described as single-use or reusable in the provided data, nor are there details on sterility or MRI safety. The devices are authorized under both FDA 510(k) and MDR (Medical Device Regulation) frameworks.

AI-generated from registry data, 18 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

Recall ongoing. 5 ongoing FDA recalls. See recalls

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Special NumberK192686 Date24 Oct 2019ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenSwedenLatviaEstoniaUnited States of AmericaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaFranceFranceAustriaHungaryRomaniaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaFranceFranceSloveniaBulgariaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaPortugalSpainSpainItalyUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSpainSpainCroatiaGreeceUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaMaltaCyprusUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Certificates: none listed in EUDAMED

Recalls

5 recalls · 5 ongoing · FDA

  • 5 recalls, same reason

    • Ongoing Z-0612-2025 FDA Class II initiated 5 Nov 2024
    • Ongoing Z-0603-2025 FDA Class II initiated 5 Nov 2024
    • Ongoing Z-0610-2025 FDA Class II initiated 5 Nov 2024
    • Ongoing Z-0606-2025 FDA Class II initiated 5 Nov 2024
    • Ongoing Z-0611-2025 FDA Class II initiated 5 Nov 2024

    GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution series CT systems, and certain operator console upgrades that can result in rotated CT images. Particularly with helical, cine, and cardiac (if applicable) scan modes, after the first image of an exam, each subsequent image can be rotated by an increasing amount. The amount of progressive image rotation is dependent on the gantry speed and the duration of the scan. The final image in the exam can be rotated up to a maximum of ~56 degrees. The entire anatomy rotates as a whole by equal degrees, without distortion, and the anatomical positioning and z-axis of the images remains correct. Small degrees of image rotation might not be noticed. If image rotation is noticed and necessitates a rescan of the patient, the same image rotation will reoccur.

Specification

EUDAMED · 510(k)

Full name
Revolution Maxima, Revolution Ace
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

Other devices from Ge Hangwei Medical Systems Co., Ltd.

See all devices from Ge Hangwei Medical Systems Co., Ltd. →

Questions

  • What clinical settings or specialties would benefit most from using the Revolution Maxima or Revolution Ace CT systems?

    The Revolution Maxima and Revolution Ace are designed for high-speed, full-coverage CT imaging, making them particularly useful in radiology departments where rapid and detailed scans are critical. Their 40 mm detector and 0.28 mm² spatial resolution enable high-quality imaging for diverse clinical applications, including emergency care, cardiology, oncology, and general diagnostic radiology. The rapid scan capabilities are especially advantageous in settings where time efficiency—such as trauma centers or high-volume imaging facilities—is essential.

  • Are the Revolution Maxima and Revolution Ace CT systems intended for single-use or reusable applications?

    The provided data does not specify whether the Revolution Maxima or Revolution Ace CT systems are single-use or reusable. These systems are large, fixed radiology equipment designed for repeated use in clinical settings, so they are unlikely to be single-use devices. However, the specific maintenance or reprocessing guidelines would depend on manufacturer recommendations, which are not detailed in the available information.

  • What regulatory pathways have the Revolution Maxima and Revolution Ace CT systems undergone, and how does this affect their use?

    The Revolution Maxima and Revolution Ace CT systems have received FDA 510(k) clearance under the Special classification (K192686) and are authorized under the Medical Device Regulation (MDR) framework. This means they have been evaluated for substantial equivalence to a predicate device and meet the regulatory requirements for safety and performance in the U.S. and EU markets, respectively. Clinicians and facilities should confirm compliance with local regulatory standards and follow manufacturer guidelines for proper installation and operation.

  • How are the Revolution Maxima and Revolution Ace CT systems supplied, and what should buyers consider when ordering?

    The Revolution Maxima and Revolution Ace CT systems are supplied by GE Hangwei Medical Systems Co., Ltd. as complete radiology equipment packages, not as disposable or single-use items. Buyers should consider factors such as facility space requirements, electrical and infrastructure compatibility, and the need for specialized training for operators. Since these are large, high-end imaging systems, they are typically installed in dedicated radiology departments rather than as portable or modular units.