FDA.reportPublic FDA data

Tomosynthesis option

Primary DI
04056869001005
Brand
Tomosynthesis option
Company
Siemens Healthcare GmbH
Model
11104944
Device description
Option to the MAMMOMAT Inspiration FFDM system to acquire tomosynthesis images for mammography
Published
2015-05-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
P140011000
P140011001
P140011002
P140011003
P140011005
P140011006
P140011007
P140011008

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P140011000MAMMOMAT INSPIRATION WITH TOMOSYNTHESIS OPTIONSiemens Medical Solutions USA, Inc.2015-04-21OTE
P140011001MAMMOMAT INSPIRATION WITH TOMOSYNTHESIS OPTIONSiemens Medical Solutions USA, Inc.2015-04-21OTE
P140011002MAMMOMAT INSPIRATION WITH TOMOSYNTHESIS OPTIONSiemens Medical Solutions USA, Inc.2015-04-21OTE
P140011003MAMMOMAT INSPIRATION WITH TOMOSYNTHESIS OPTIONSiemens Medical Solutions USA, Inc.2015-04-21OTE
P140011005MAMMOMAT INSPIRATION WITH TOMOSYNTHESIS OPTIONSiemens Medical Solutions USA, Inc.2015-04-21OTE
P140011006MAMMOMAT INSPIRATION WITH TOMOSYNTHESIS OPTIONSiemens Medical Solutions USA, Inc.2015-04-21OTE
P140011007MAMMOMAT INSPIRATION WITH TOMOSYNTHESIS OPTIONSiemens Medical Solutions USA, Inc.2015-04-21OTE
P140011008MAMMOMAT INSPIRATION WITH TOMOSYNTHESIS OPTIONSiemens Medical Solutions USA, Inc.2015-04-21OTE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04056869001005PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04056869001005040568690010054056869001005

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)888-7436XX@XX.XX
+1(800)888-7436CONTACT@SIEMENS-HEALTHINEERS.COM

Regulatory Flags#

DUNS number
313217003
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04056869993973LUMINOS Q.namix R11574002115740022025-07-30
04056869993980LUMINOS Q.namix T11574003115740032025-07-30
04056869987187MAMMOMAT B.brilliant11372950113729502024-04-20
04056869009179Multitom Rax10860700108607002016-09-24
04068151011807ARTIS icono.explore floor118320002026-05-15
04068151018226syngo Application Software118312342026-05-15
04068151033779ARTIS genio floor118321002026-05-15
04056869991771myAblation Guide108313732026-05-11
04056869295923ARTIS icono ceiling113281002022-10-01
04056869263168NAEOTOM Alpha113300032021-10-13
04056869063317ARTIS icono biplane113276002020-01-10
04056869149325ARTIS icono floor113277002020-01-10
04056869046877ARTIS pheno108490002017-05-15
04068151033977AI-Rad companion Brain MR118304812026-04-14
04068151020076syngo Dynamics117081242026-03-19
04056869973371AI-Rad Companion Organs RT116655082025-04-30
04068151036749MAGNETOM Flow.Rise117884172026-01-20
04056869299556MAGNETOM Flow.Neo115698352026-01-19
04056869299594MAGNETOM Flow.Neo115698392026-01-19
04068151034196MAGNETOM Flow.Elite118519112026-01-19

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