Digital Breast Tomosynthesis

Product Code: OTE

Medical Diagnostic X-Ray Equipment

Definition: To Generate Digital 3d Mammographic Images That Can Be Used For The Screening And Diagnosis Of Breast Cancer.

Applicable Standards: Diagnostic X-ray Systems And Their Major Components. [1020.30] Radiographic Equipment. [1020.31] Fluoroscopic Equipment. [1020.32] Computed Tomography (CT) Equipment. [1020.33]

Code of Federal Regulations:


Radiation TypeIonizing
Radition SafetyProduct
Annual ReportsYes

Products Classified as OTE

5445Digital Breast Tomosynthesis

Total Product Life Cycle (TPLC) Devices

5445Digital Breast Tomosynthesis

FDA Consensus Standards

Digital Breast Tomosynthesis [33222]21 CFR Unclassified 🔎

Pre-market Approvals for OTE

P140011MAMMOMAT INSPIRATION WITH TOMOSYNTHESIS OPTIONSIEMENS MEDICAL SOLUTIONS USA, INC.
P080003Selenia Dimensions/3Dimensions 3D SystemHOLOGIC, INC.
P130020Senographe Pristina 3DGE Healthcare
P160031ASPIRE Cristalle Breast Tomosynthesis SystemFUJIFILM MEDICAL SYSTEMS U.S.A., INC.

Global Unique Device Identification Database

04547410351316Digital breast tomosynthesis
04056869001005Digital Breast Tomosynthesis
15420045508033Digital breast tomosynthesis
15420045508026Digital breast tomosynthesis
15420045508019Digital breast tomosynthesis
15420045507296Digital breast tomosynthesis
15420045507289Digital breast tomosynthesis
15420045507272Digital breast tomosynthesis
15420045500020Digital breast tomosynthesis
15420045500013Digital breast tomosynthesis
15420045510395Digital breast tomosynthesis
15420045512313Digital breast tomosynthesis
15420045511897Digital breast tomosynthesis
15420045510388Digital breast tomosynthesis
00840682142038Digital breast tomosynthesis

Maude Adverse Events

SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS, 3DHOLOGIC, INC2020-03-24
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SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS, 3DHOLOGIC, INC2020-03-16
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SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS, 3DHOLOGIC, INC2020-03-03
3DIMENSIONSHOLOGIC, INC2020-02-28
SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS, 3DHOLOGIC, INC2020-02-25
SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS, 3DHOLOGIC, INC2020-02-20
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SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS, 3DHOLOGIC, INC2020-02-12
SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS, 3DHOLOGIC, INC2020-02-11
SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS,3DHOLOGIC, INC2020-02-10
SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS, 3DHOLOGIC, INC2020-02-05
SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS, 3DHOLOGIC, INC2020-02-03
SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS, 3DHOLOGIC, INC2020-01-21
SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS, 3DHOLOGIC, INC2020-01-17
SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS, 3DHOLOGIC, INC2020-01-09
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SELENIA DIMENSIONS MAMMOGRAPHY SYSTEM, 3DHOLOGIC, INC2019-11-25
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SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS, 3DHOLOGIC, INC2019-10-21
SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS, 3DHOLOGIC, INC2019-10-14
SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS, 3DHOLOGIC, INC2019-10-14
SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS, 3DHOLOGIC, INC2019-10-10
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SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS, 3DHOLOGIC, INC2019-09-24
SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS, 3DHOLOGIC, INC2019-09-24
3DIMENSIONSHOLOGIC, INC2019-09-18
SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS, 3DHOLOGIC, INC2019-08-30
SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS, 3DHOLOGIC, INC2019-08-30
SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS, 3DHOLOGIC, INC2019-08-22
SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS, 3DHOLOGIC, INC2019-08-05
SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS, 3DHOLOGIC, INC2019-07-30
SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS, 3D2019-07-29
SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS, 3DHOLOGIC, INC2019-07-22
SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS, 3DHOLOGIC, INC2019-07-22
ASPIRE CRISTALLEFUJIFILM CORPORATION2019-07-10
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