FDA.reportPublic FDA data

not applicable

Primary DI
00195278560049
Brand
not applicable
Company
GE MEDICAL SYSTEMS
Model
PRISTINA 2.8
Device description
Software Pristina 8.1 - ISO file
Published
2022-12-01
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
K173576000
K182951000
K193334000
K211215000
K211725000
P130020002

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K162268000Senographe PristinaGE Healthcare2016-11-03MUE
K173576000Pristina SerenaGE Healthcare2018-05-14MUE
K182951000Pristina Serena 3DGE Healthcare2019-01-18MUE
K193334000Pristina Serena BrightGE Healthcare2020-05-15MUE
K211215000SenoBright HDGE Healthcare2021-06-22MUE
K211725000Senographe PristinaGE Healthcare2021-08-06MUE
P130020002SENOCLAIREGE Healthcare2014-08-26OTE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00195278560049PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00195278560049001952785600491952785600490195278560049

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
266062561
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00198953076873SenoIris12025-11-24
00840682102384AW Server3.22016-08-01
00195278661999Senographe PristinaNAY22023-07-28
00195278485144AlliaIGS 558728922022-04-13
00195278347596Pristina SerenaKAS22021-04-26
00195278022745Senographe PristinaEKB42021-05-21
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
00840682122603not applicable57276692017-09-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
15420045515796EnvisionHologic, Inc.OTE2026-10-09
15420045515802EnvisionHologic, Inc.OTE2026-10-09
15420045515864EnvisionHologic, Inc.OTE2026-10-09
15420045515871EnvisionHologic, Inc.OTE2026-10-09
15420045515895EnvisionHologic, Inc.OTE2026-10-09
15420045517462EnvisionHologic, Inc.OTE2026-10-09
15420045517479EnvisionHologic, Inc.OTE2026-10-09
008548100070693600IcRco, Inc.MUE2026-07-22
08809394330807Bellalun 2DVIEWORKS CO., LTD.MUE2026-07-20
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
00198953109281Senographe PristinaGE MEDICAL SYSTEMSMUE2025-12-01
00198953109281Senographe PristinaGE MEDICAL SYSTEMSOTE2025-12-01
10198953054311not applicableGE MEDICAL SYSTEMSOTE2025-11-28
10198953054311not applicableGE MEDICAL SYSTEMSMUE2025-11-28
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