FDA.reportPublic FDA data

Revolution

Primary DI
00840682137553
Brand
Revolution
Company
GE Hangwei Medical Systems Company Ltd.
Model
Frontier
Device description
Revolution Frontier CT Designated medical device
Published
2018-04-20
Public version status
Update
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
K120833000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K120833000DISCOVERY CT750 HDGe Medical Systems, LLC2012-06-12JAK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840682137553PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840682137553008406821375538406821375530840682137553

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
554408642
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00195278940292RevolutionMaxima QURevolutionMaxima2025-02-28
00195278907202RevolutionRTRevolutionRT2025-03-31
00195278923257RevolutionMaxima QRevolutionMaxima2025-03-05
00195278809810RevolutionRTRevolutionRT2024-12-26
00195278362230RevolutionFrontier MDR2022-08-16
00195278362247RevolutionFrontier ES2022-08-16
00195278385215RevolutionAdvanceRevolutionAdvance2021-06-11
00195278403087RevolutionEagle2021-06-11
00195278435675RevolutionFrontier Gen 3_HD Refresh PackageB79832DA2026-04-17
00195278466488RTRefresh Package2026-04-17
00195278505798Operator Consolefor BrightSpeed Elite and BrightSpeed Elite Select2026-04-17
00195278882677NAConsole Generation UpgradeConsoleGenerationUpgrade2026-04-17
00198953049174RevolutionMaxima QFRevolutionMaxima2025-10-15
00198953049631RevolutionMaxima QIRevolutionMaxima2025-09-09
00195278943934RevolutionVibe2025-08-22
00195278798107RevolutionAscend Sliding2024-02-28
00195278788665Revolution ApexSelect with Plus EditionB7919YO2023-12-26
00195278686718RevolutionMaxima HB82512DA-B82502DA-B82492DA2023-06-22
00195278469700RevolutionApex SelectB7919QT-B7919QS2022-02-04
00195278363947MaxFOV 21.0NA2021-09-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198953147481RevolutionGE Medical Systems, L.L.C.JAK2026-11-03
04547410575392Synapse 3DFUJIFILM CORPORATIONJAK2026-10-30
08800025300374AVIEW Aorta MetricsCORELINE SOFT CO.,LTD.JAK2026-10-29
M722CD26272CA252790ClearRead CT CAC DockerRiverain Technologies, Inc.JAK2026-10-28
00198953050996SnapShot FreezeGE Medical Systems, L.L.C.JAK2026-10-19
03760305400246DUAL SIDED NEEDLE GUIDEQUANTUM SURGICALJAK2026-10-19
03760305400277PATIENT REFERENCE 2.0QUANTUM SURGICALJAK2026-10-19
19356870000045CAC4DMEDICAL LIMITEDJAK2026-10-13
19356870000090LDA4DMEDICAL LIMITEDJAK2026-10-13
00860016243804C-beamPulmera, Inc.JAK2026-10-10
00884838120433SmartCTPhilips Medical Systems Nederland B.V.JAK2026-09-28
00850025268431Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2026-09-21
00860015781925Bunkerhill Contrast AVCBunkerhill Health Inc.JAK2026-09-16
00884838129559CT Areta RT/Rembra RT UpgradesPhilips Healthcare (Suzhou) Co., Ltd.JAK2026-08-21
00850025268417Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2026-06-05
10810068810940MONARCH™ Advanced Imaging Accessory KitAuris Health, Inc.JAK2026-06-02
00860015781918iCAC DeviceBunkerhill Health Inc.JAK2026-05-31
10810068810841MONARCH™ Navigation SensorsAuris Health, Inc.JAK2026-05-27
00860015781901CAC (Gated) AlgorithmBunkerhill Health Inc.JAK2026-05-13
00850025268424Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2026-05-12
00198953085950PhotonovaGE Medical Systems, L.L.C.JAK2026-05-11
00884838129528CT RembraPhilips Healthcare (Suzhou) Co., Ltd.JAK2026-04-03
00884838129535CT Rembra RTPhilips Healthcare (Suzhou) Co., Ltd.JAK2026-04-03
00884838129542CT Areta RTPhilips Healthcare (Suzhou) Co., Ltd.JAK2026-04-03
00850025268400Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2026-02-27
00850025268394Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2026-01-21
00850025268387Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2025-11-03
00850025268370Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2025-09-24
06971576832231uMIShanghai United Imaging Healthcare Co., Ltd.JAK2025-08-03
06971576832255uMIShanghai United Imaging Healthcare Co., Ltd.JAK2025-08-03