FDA.reportPublic FDA data

Senographe Pristina

Primary DI
00198953109281
Brand
Senographe Pristina
Company
GE MEDICAL SYSTEMS
Model
POZ2
Device description
Senographe Pristina UDI
Published
2025-12-01
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
MUEFull Field Digital, System, X-Ray, Mammographic
OTEDigital Breast Tomosynthesis

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MUEFull Field Digital, System, X-Ray, MammographicRadiology2
OTEDigital Breast TomosynthesisUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K162268000
K260087000
P130020002
P130020005

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K162268000Senographe PristinaGE Healthcare2016-11-03MUE
K260087000Senographe Pristina; SenoBright HD; Pristina Serena; Pristina Serena BrightGE Medical Systems SCS2026-03-24MUE
P130020002SENOCLAIREGE Healthcare2014-08-26OTE
P130020005SENOCLAIREGE Healthcare2014-08-26OTE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00198953109281PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00198953109281001989531092811989531092810198953109281

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
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
00840682123242Senographe EssentialES142016-12-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08052405210203SERENYS DRMETALTRONICA SPAMUE2026-05-25
08052405210050HELIANTHUSMETALTRONICA SPAMUE2026-03-24
15420045518131Selenia® Dimensions®Hologic, Inc.OTE2026-03-12
15420045518148Selenia® Dimensions®Hologic, Inc.OTE2026-03-12
15420045518155Selenia® Dimensions®Hologic, Inc.OTE2026-03-12
15420045518162Selenia® Dimensions®Hologic, Inc.OTE2026-03-12
15420045518179Selenia® Dimensions®Hologic, Inc.OTE2026-03-12
15420045518186Selenia® Dimensions®Hologic, Inc.OTE2026-03-12
15420045518193Selenia® Dimensions®Hologic, Inc.OTE2026-03-12
15420045518216Selenia® Dimensions®Hologic, Inc.OTE2026-03-12
15420045518223Selenia® Dimensions®Hologic, Inc.OTE2026-03-12
15420045518230Selenia® Dimensions®Hologic, Inc.OTE2026-03-12
10198953054311not applicableGE MEDICAL SYSTEMSMUE2025-11-28
10198953054311not applicableGE MEDICAL SYSTEMSOTE2025-11-28
15420045516236EnvisionHologic, Inc.OTE2025-11-13
15420045516243EnvisionHologic, Inc.OTE2025-11-13
15420045516250EnvisionHologic, Inc.OTE2025-11-13
15420045516267EnvisionHologic, Inc.OTE2025-11-13
15420045516274EnvisionHologic, Inc.OTE2025-11-13
15420045516281EnvisionHologic, Inc.OTE2025-11-13
15420045516304EnvisionHologic, Inc.OTE2025-11-13
15420045516311EnvisionHologic, Inc.OTE2025-11-13
15420045516328EnvisionHologic, Inc.OTE2025-11-13
15420045516335EnvisionHologic, Inc.OTE2025-11-13
15420045516342EnvisionHologic, Inc.OTE2025-11-13
15420045516359EnvisionHologic, Inc.OTE2025-11-13
15420045516366EnvisionHologic, Inc.OTE2025-11-13
15420045516373EnvisionHologic, Inc.OTE2025-11-13
15420045516380EnvisionHologic, Inc.OTE2025-11-13
15420045516397EnvisionHologic, Inc.OTE2025-11-13