FDA.reportPublic FDA data

NA

Primary DI
00195278882677
Brand
NA
Company
GE Hangwei Medical Systems Company Ltd.
Model
Console Generation Upgrade
Catalog number
ConsoleGenerationUpgrade
Device description
Console Generation Upgrade_Designated Medical Device
Published
2026-04-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
JAKSystem, X-Ray, Tomography, Computed

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JAKSystem, X-Ray, Tomography, ComputedRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K110227000
K131576000
K192686000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K110227000OPTIMA CT660Ge Medical Systems, LLC2011-07-20JAK
K131576000OPTIMA CT660Ge Medical Systems, LLC2013-08-30JAK
K192686000Revolution Maxima, Revolution AceGe Hangwei Medical Systems Co., Ltd.2019-10-24JAK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00195278882677PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00195278882677001952788826771952788826770195278882677

GMDN Terms#

Term, Definition table
TermDefinition
Full-body CT systemAn assembly of diagnostic x-ray computed tomography (CT) devices with a gantry large enough to allow imaging of any part of the body. It includes designs with single or multiple fixed annular arrays of x-ray tubes and opposing detectors or those with x-ray tube(s) and opposing detector assemblies that rotate rapidly around a central axis point within the gantry imaging area. It can produce two and/or three-dimensional (3-D) cross-sectional (tomographic) images, including spiral CT or other special imaging applications at multiple specified angles in relation to body position. It may use a variety of digital techniques for information capture, image reconstruction, and display.

Regulatory Flags#

DUNS number
554408642
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00195278435675RevolutionFrontier Gen 3_HD Refresh PackageB79832DA2026-04-17
00195278466488RTRefresh Package2026-04-17
00195278505798Operator Consolefor BrightSpeed Elite and BrightSpeed Elite Select2026-04-17
00198953049174RevolutionMaxima QFRevolutionMaxima2025-10-15
00198953049631RevolutionMaxima QIRevolutionMaxima2025-09-09
00195278943934RevolutionVibe2025-08-22
00195278907202RevolutionRTRevolutionRT2025-03-31
00195278923257RevolutionMaxima QRevolutionMaxima2025-03-05
00195278940292RevolutionMaxima QURevolutionMaxima2025-02-28
00195278809810RevolutionRTRevolutionRT2024-12-26
00195278798107RevolutionAscend Sliding2024-02-28
00195278788665Revolution ApexSelect with Plus EditionB7919YO2023-12-26
00195278686718RevolutionMaxima HB82512DA-B82502DA-B82492DA2023-06-22
00195278362230RevolutionFrontier MDR2022-08-16
00195278362247RevolutionFrontier ES2022-08-16
00195278469700RevolutionApex SelectB7919QT-B7919QS2022-02-04
00195278363947MaxFOV 21.0NA2021-09-14
00195278385215RevolutionAdvanceRevolutionAdvance2021-06-11
00195278403087RevolutionEagle2021-06-11
00840682147392RevolutionMaxima US2020-12-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10810068810940MONARCH™ Advanced Imaging Accessory KitAuris Health, Inc.JAK2026-06-02
00860015781918iCAC DeviceBunkerhill Health Inc.JAK2026-05-31
10884521785977superDimensionCovidien LPJAK2026-05-29
10884521851184superDimensionCovidien LPJAK2026-05-29
10810068810841MONARCH™ Navigation SensorsAuris Health, Inc.JAK2026-05-27
10810068810858MONARCH™ ControllerAuris Health, Inc.JAK2026-05-27
M722CD26112CA252790ClearRead CT CAC DockerRiverain Technologies, Inc.JAK2026-05-07
B319LSN1LSNIMAGING BIOMETRICS, LLCJAK2026-04-14
B720BX360ELUNG230Brainomix 360 e-LungBRAINOMIX LIMITEDJAK2026-03-30
08719326703824LungQ®Thirona B.V.JAK2026-02-12
10841962119457Symphony Locating Bar, Prodigy2™QfixJAK2025-10-23
10841962119464Symphony Locating Bar, PH StyleQfixJAK2025-10-23
M722C25281CA252790ClearRead CT CAC ServerRiverain Technologies, Inc.JAK2025-10-17
M722CC25281CA252790ClearRead CT CAC ConsoleRiverain Technologies, Inc.JAK2025-10-17
M722CD25281CA252790ClearRead CT CAC DockerRiverain Technologies, Inc.JAK2025-10-17
10810068811275Extended Patient Introducer MountAuris Health, Inc.JAK2025-09-04
10810068810896Monarch Bronchscope 2.0/Monarch Platform (P2), RefurbishedAuris Health, Inc.JAK2025-08-04
10810068811169Monarch Platform, Bronchoscopy 4.1, RefurbishedAuris Health, Inc.JAK2025-08-04
10810068811497Monarch™ Tower Software v4.1.1Auris Health, Inc.JAK2025-06-04
10810068811503Monarch™ Cart Software v4.1.1Auris Health, Inc.JAK2025-06-04
10884521852198superDimensionCovidien LPJAK2025-05-18
08800025300299AVIEWCORELINE SOFT CO.,LTD.JAK2025-03-27
08800025300367AVIEW CACCORELINE SOFT CO.,LTD.JAK2025-03-24
10810068810971Monarch Endoscopy ControllerAuris Health, Inc.JAK2025-03-05
10810068810988Monarch Platform, Bronchoscopy 4.1Auris Health, Inc.JAK2025-03-03
10810068810582Monarch™ Tower Software v4.1.0Auris Health, Inc.JAK2025-03-03
10810068810599Monarch™ Cart Software v4.1.0Auris Health, Inc.JAK2025-03-03
M722CD25030CA241430ClearRead CT CAC DockerRiverain Technologies, Inc.JAK2025-02-12
04987670105579Aquilion ONECANON INC.JAK2025-01-09
07640167220021CAS-One IR Consumable Set GeneralCAScination AGJAK2024-06-17