FDA.reportPublic FDA data

EasyDiagnost Eleva

Primary DI
00884838074255
Brand
EasyDiagnost Eleva
Company
Philips Medical Systems DMC GmbH
Model
9890-010-03632
Catalog number
706050
Device description
Table, Radiographic, Tilting
Published
2016-09-19
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
IXRTable, radiographic, tilting

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IXRTable, Radiographic, TiltingRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K970640000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K970640000PHILIPS EASY DIAGNOSTPhilips Medical Systems North America, Inc.1997-03-21IXR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00884838074255PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884838074255008848380742558848380742550884838074255

GMDN Terms#

Term, Definition table
TermDefinition
Stationary general-purpose fluoroscopic x-ray system, digitalA stationary general-purpose diagnostic fluoroscopic x-ray system that uses real-time digital techniques for image capture, display and manipulation and is specifically designed to be used in a variety of general-purpose applications requiring real-time fluoroscopic imaging. It includes spot-film capabilities in addition to the fluoroscopic features and is intended to optimize the capability of users to visually and quantitatively evaluate the anatomy and physiological function of various targeted body areas in real-time. It is frequently used in conjunction with an ingested or injected x-ray contrast medium. Images can be viewed in both real-time and delayed format.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
314101218
Device count
1
Combination product
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00884838115521Radiography 7000 M7120102024-02-22
00884838116016Radiography 7300 C7120372024-06-27
00884838103221ProxiDiagnost N907061102022-01-17
00884838101456CombiDiagnost R907090312021-02-04
00884838090699DigitalDiagnost C907120342019-03-28
00884838090705DigitalDiagnost C907120352019-03-28
00884838065321DigitalDiagnost7120317120312016-09-19
00884838074514DigitalDiagnost7120327120322016-09-19
00884838074521DigitalDiagnost7120337120332016-09-19
00884838102842Telemetry Monitor 5500 1.4 GHz RadioTelemetry Monitor 5500 1.4 GHz Radio8672322026-04-27
00884838076747CombiDiagnost R907090307090302018-05-09
00884838127517CT XS Tube CPO9806-058-000919806-058-000912025-07-31
00884838125322Grid Landscape for SkyPlate E 9896-010-725122025-06-19
00884838125339Grid Landscape for SkyPlate large 9896-010-686242025-06-19
00884838125346Grid Portrait for SkyPlate E 9896-010-725022025-06-19
00884838125353Grid Portrait for SkyPlate large9896-010-686332025-06-19
00884838125360Grid Portrait for SkyPlate small 9896-010-686442025-06-19
00884838125384Grid Portrait Fiber PaxScan4336W9896-010-708322025-06-19
00884838125391Grid Landscape Fiber PaxScan4336W9896-010-708222025-06-19
00884838125421X-Ray Grid 40/12/1409896-010-648922025-06-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07350006950148Sonesta F3Sonesta Medical ABIXR2025-10-14
07350006950049Sonesta F3Sonesta Medical ABIXR2025-09-30
00198953043301NAGE Hualun Medical Systems Co., LtdIXR2025-04-22
00850061871015IMAGE DIAGNOSTICS INCIMAGE DIAGNOSTICS, INC.IXR2024-04-03
00850061871022IMAGE DIAGNOSTICS INCIMAGE DIAGNOSTICS, INC.IXR2024-04-03
00850061871008IMAGE DIAGNOSTICS INCIMAGE DIAGNOSTICS, INC.IXR2024-02-23
00850977007997IMAGE DIAGNOSTICS INCIMAGE DIAGNOSTICS, INC.IXR2024-02-23
00817463026405Oakworks MedicalOAKWORKS, INC.IXR2023-12-06
00817463026412Oakworks Medical OAKWORKS, INC.IXR2023-12-06
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00817463026245Oakworks MedicalOAKWORKS, INC.IXR2023-07-10
00817463026269Oakworks MedicalOAKWORKS, INC.IXR2023-07-10
00817463026283Oakworks MedicalOAKWORKS, INC.IXR2023-07-10