FDA.reportPublic FDA data

Selenia Dimensions 3D System

Primary DI
15420045500013
Brand
Selenia Dimensions 3D System
Company
Hologic, Inc.
Model
3D software
Catalog number
SW-01648
Device description
Selenia® Dimensions® digital mammography system generates digital mammographic images that can be used for screening and diagnosis of breast cancer.
Published
2014-09-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OTEDigital breast tomosynthesis

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OTEDigital Breast TomosynthesisUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P080003000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P080003000SELENIA DIMENSIONS FULL FIELD DIGITAL MAMMOGRAPHY SYSTEMHologic, Inc.2011-02-11OTE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15420045500013PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1542004550001315420045500013

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).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)442-9892CustomerSupport@hologic.com

Regulatory Flags#

DUNS number
139534114
Device count
1
DM exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
25420045516691RESPDIRECT™RESPDIRECT COLLECTION KIT, US-KIT, BOXPRD-077882023-08-14
00850346007030CoolSeal™ TrinityCSL-TR105-30CSL-TR105-302020-10-13
00850346007047CoolSeal™ TrinityCSL-TR105-37CSL-TR105-372020-10-13
00850346007061CoolSeal™ TrinityCSL-TR105-44CSL-TR105-442020-10-13
00850346007092CoolSeal™ RevealCSL-RV105-10CSL-RV105-102021-05-19
00850346007085CoolSeal™ MiniCSL-MN103-20CSL-MN103-202020-10-13
15420045500372ProcleixUltrio Plus 1K3025732014-08-06
15420045500389ProcleixUltrio Plus 1K3025732014-08-06
15420045500396ProcleixUltrio Plus 1K3025732014-08-06
15420045500402ProcleixUltrio Plus 1K3025732014-08-06
15420045500419ProcleixUltrio Plus 5K3025742014-08-06
15420045500426ProcleixUltrio Plus 5K3025742014-08-06
15420045500433ProcleixUltrio Plus 5K3025742014-08-06
15420045500440ProcleixUltrio Plus 5K3025742014-08-06
15420045500457ProcleixUltrio Plus 5K3025742014-08-06
15420045500464ProcleixUltrio Plus, HIV-1 D-Probes3025712014-08-06
15420045500471ProcleixUltrio Plus HBV D-Probes3025762014-08-06
15420045500488ProcleixUltrio Plus HCV D-Probes3025772014-08-06
15420045500495ProcleixUltrio Plus TIGRIS Controls3025722014-08-06
15420045500501ProcleixUltrio Plus Calibrators3025752014-08-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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 SYSTEMSOTE2025-12-01
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
15420045516403EnvisionHologic, Inc.OTE2025-11-13
15420045516410EnvisionHologic, Inc.OTE2025-11-13