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Revolution ACT

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

Active European Union and United States

510(k) K171013

Overview

The Revolution ACT is a computed tomography (CT) system designed for head and whole-body imaging. It integrates a gantry, transporter, operator console with host computer, power distribution unit, and interconnection cables, alongside image acquisition and reconstruction hardware/software. This device enables high-resolution cross-sectional imaging for diagnostic radiology applications.

The system is supplied as a complete unit, including accompanying documentation, and is intended for use in radiology departments. It is classified under product code JAK and has received FDA 510(k) clearance (K171013) as substantially equivalent to predicate devices. No specific sterility or single-use/reusable designation is stated in the provided data.

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

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK171013 Date5 Jun 2017ClearedStatusActive
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

Recalls: none on record (FDA, checked 22 Oct 2026)

Certificates: none listed in EUDAMED

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

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Questions

  • What types of medical imaging can the Revolution ACT perform, and how does it differ from standard CT scanners?

    The Revolution ACT is specifically designed for high-resolution head and whole-body imaging, allowing detailed cross-sectional scans for diagnostic radiology. Unlike standard CT scanners, it integrates a gantry, transporter, operator console, and specialized hardware/software for seamless image acquisition and reconstruction, making it suitable for comprehensive diagnostic evaluations in radiology departments.

  • Is the Revolution ACT system supplied as a complete package, or do I need to purchase additional components separately?

    The Revolution ACT is supplied as a complete unit, including the gantry, transporter, operator console with host computer, power distribution unit, interconnection cables, and all necessary hardware/software for imaging. No additional components are required beyond the accompanying documentation provided with the system.

  • How is the Revolution ACT regulated, and what does its FDA 510(k) clearance mean for its use in clinical settings?

    The Revolution ACT received FDA 510(k) clearance (K171013) under the product code JAK, confirming it is substantially equivalent to predicate CT systems. This means it meets regulatory standards for safety and effectiveness as determined by the FDA’s Radiology Advisory Committee (RA), allowing its use in clinical settings for diagnostic radiology applications as described in its labeling.

  • Can the Revolution ACT be used for both head and body imaging, or is it limited to one area?

    The Revolution ACT is explicitly designed for both head and whole-body imaging, enabling versatile diagnostic applications. Its high-resolution capabilities allow radiologists to capture detailed cross-sectional images across the entire body, making it suitable for comprehensive evaluations rather than being restricted to a single anatomical region.