FDA.reportPublic FDA data

not applicable

Primary DI
00840682122603
Brand
not applicable
Company
GE MEDICAL SYSTEMS
Model
5727669
Device description
Self-Compression Solution
Published
2017-09-13
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
00840682122603PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840682122603008406821226038406821226030840682122603

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 Pressure50 KiloPascal106 KiloPascal
Handling Environment Humidity5 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Handling Environment Temperature15 Degrees Celsius40 Degrees Celsius
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity5 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
00195278925428Pristina PaddleSLD LS2025-01-09
00195278527899Pristina PaddleSLD 2D PF2022-05-02
00195278527950Pristina Paddle19X23SLD2022-03-09
00195278527882Pristina Paddle24x29 STD2022-03-08
00195278527912Pristina Paddle24x29 FLEX2022-03-08
00195278527929Pristina PaddleSLD IMP2022-03-08
00195278527936Pristina PaddleSLD RND2022-03-08
00195278527943Pristina PaddleSLD 2D2022-03-08
00195278527905Pristina PaddleSLD SQR2022-03-07
00195278330390Pristina PaddleSLD FX2021-01-14
00198953109281Senographe PristinaPOZ22025-12-01
00198953052488AlliaMoveo59818762025-12-17
10198953054311not applicablePRISTINA 2.102025-11-28
00198953076873SenoIris12025-11-24
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
008548100070693600IcRco, Inc.MUE2026-07-22
08809394330807Bellalun 2DVIEWORKS CO., LTD.MUE2026-07-20
00195278925428Pristina PaddleGE MEDICAL SYSTEMSFMQ2025-01-09
04056869987187MAMMOMAT B.brilliantSiemens Healthcare GmbHMUE2024-04-20
00195278527899Pristina PaddleGE MEDICAL SYSTEMSFMQ2022-05-02
00195278527950Pristina PaddleGE MEDICAL SYSTEMSFMQ2022-03-09
00195278527882Pristina PaddleGE MEDICAL SYSTEMSFMQ2022-03-08
00195278527912Pristina PaddleGE MEDICAL SYSTEMSFMQ2022-03-08
00195278527929Pristina PaddleGE MEDICAL SYSTEMSFMQ2022-03-08
00195278527936Pristina PaddleGE MEDICAL SYSTEMSFMQ2022-03-08
00195278527943Pristina PaddleGE MEDICAL SYSTEMSFMQ2022-03-08
00195278527905Pristina PaddleGE MEDICAL SYSTEMSFMQ2022-03-07
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
00195278330390Pristina PaddleGE MEDICAL SYSTEMSFMQ2021-01-14
08059307491358C30I.A.E. INDUSTRIA APPLICAZIONI ELETTRONICHE SPAITY2020-08-24
08436035354092SalvacelMEDI CARE SYSTEM SLUFMQ2019-11-26
08436035355907Salvafix Memory PROMEDI CARE SYSTEM SLUFMQ2019-11-26
08436035355921Salvafix Memory PROMEDI CARE SYSTEM SLUFMQ2019-11-26
08436035355945Salvafix Memory PROMEDI CARE SYSTEM SLUFMQ2019-11-26
08436035355969Salvafix Memory PROMEDI CARE SYSTEM SLUFMQ2019-11-26
08436035355983Salvafix Memory PROMEDI CARE SYSTEM SLUFMQ2019-11-26
08436035356003Salvafix Memory PROMEDI CARE SYSTEM SLUFMQ2019-11-26