FDA.reportPublic FDA data

Senographe Pristina

Primary DI
00840682118460
Brand
Senographe Pristina
Company
GE MEDICAL SYSTEMS
Model
EKB1
Published
2016-11-16
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
FMQRestraint, protective
ITYAssembly, tube housing, x-ray, diagnostic
IWXBarrier, control panel, x-ray, movable
IXJGrid, radiographic
IZOGenerator, high-voltage, x-ray, diagnostic
IZWCollimator, automatic, radiographic
MUEFull field digital,system,x-ray,mammographic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMQRestraint, ProtectiveGeneral Hospital1
ITYAssembly, Tube Housing, X-Ray, DiagnosticRadiology1
IWXBarrier, Control Panel, X-Ray, MovableRadiology1
IXJGrid, RadiographicRadiology1
IZOGenerator, High-Voltage, X-Ray, DiagnosticRadiology1
IZWCollimator, Automatic, RadiographicRadiology2
MUEFull Field Digital, System, X-Ray, MammographicRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K162268000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K162268000Senographe PristinaGE Healthcare2016-11-03MUE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840682118460PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840682118460008406821184608406821184600840682118460

GMDN Terms#

Term, Definition table
TermDefinition
Stationary mammographic x-ray system, digitalA stationary assembly of devices designed to generate x-ray images of the breast using digital techniques for image capture and display. It is designed specifically to compress the breast during imaging and is intended to visually evaluate the anatomy and function of blood and lymphatic vessels within the breast. Often referred to as a digital mammography system (DMS) it is typically used for breast cancer screening or during biopsy procedures (e.g., placement of biopsy markers, stereotactic biopsy). It is designed to capture two-dimensional (2-D) x-ray images, however may include software intended to process multiple images to create a three-dimensional (3-D) image/model (tomosynthesis).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Handling Environment Humidity10 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Handling Environment Temperature15 Degrees Celsius30 Degrees Celsius
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-40 Degrees Celsius70 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
266062561
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00198953109281Senographe PristinaPOZ22025-12-01
00198953052488AlliaMoveo59818762025-12-17
10198953054311not applicablePRISTINA 2.102025-11-28
00198953076873SenoIris12025-11-24
00840682122603not applicable57276692017-09-13
00840682108621INNOVAIGS 620 0022016-08-01
00840682108638INNOVAIGS 630 0022016-08-01
00840682110129INNOVAIGS 520 0022016-08-01
00840682110648DISCOVERYIGS 730 0022016-08-01
00840682110662INNOVAIGS 530 0022016-08-01
00840682110693DISCOVERYIGS 740 0022016-08-01
00840682110709INNOVAIGS 540 0022016-08-01
00840682124621INNOVAIGS 5 0012018-01-24
00840682124638DISCOVERYIGS 7 0012018-02-11
00840682125888DISCOVERYIGS 7 OR 0012018-02-10
00840682141581INTERACT DiscoveryRT 0012018-06-14
00840682147378INNOVAIGS 3 0012020-02-03
00840682121637INNOVAUPG X100 0012016-09-24
00840682100076SenoClaireLLH25434135-52015-01-22
00840682121064SenoBrightGPE12016-08-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G242LPSGS24249Techno-AideTechno-Aide, Inc.IWX2023-10-20
G242LPSGS24369Techno-AideTechno-Aide, Inc.IWX2023-10-20
G242LPSGS24489Techno-AideTechno-Aide, Inc.IWX2023-10-20
G242LPSH36369Techno-AideTechno-Aide, Inc.IWX2023-10-20
G242LPSH48489Techno-AideTechno-Aide, Inc.IWX2023-10-20
G242LPSS24249Techno-AideTechno-Aide, Inc.IWX2023-10-20
G242LPSS24369Techno-AideTechno-Aide, Inc.IWX2023-10-20
G242LPSS24489Techno-AideTechno-Aide, Inc.IWX2023-10-20
G242LPST2424S9Techno-AideTechno-Aide, Inc.IWX2023-10-20
G242LPST2430S9Techno-AideTechno-Aide, Inc.IWX2023-10-20
08056977360007GIOTTO CLASSIMS GIOTTO SPAMUE2021-03-23
08056977360014GIOTTO CLASS IMS GIOTTO SPAMUE2021-03-23
08056977360038GIOTTO CLASS IMS GIOTTO SPAMUE2021-03-23
08056977360045GIOTTO CLASS IMS GIOTTO SPAMUE2021-03-23
08056977360052GIOTTO CLASS IMS GIOTTO SPAMUE2021-03-23
08056977360069GIOTTO IMAGE IMS GIOTTO SPAMUE2021-03-23
08056977360076GIOTTO IMAGEIMS GIOTTO SPAMUE2021-03-23
08056977360083GIOTTO IMAGE IMS GIOTTO SPAMUE2021-03-23
08056977360106MAMMOBEDIMS GIOTTO SPAMUE2021-03-23
08059307491358C30I.A.E. INDUSTRIA APPLICAZIONI ELETTRONICHE SPAITY2020-08-24
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08436035356751Salvafix Memory PROMEDI CARE SYSTEM SLUFMQ2019-11-26