Selenia® Dimensions® digital mammography system is a mammographic system used for capturing digital x
Selenia Dimensions - SDM-SYS-6000-2D
Device Description
A 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).
Environmental Conditions
No Data Available
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: OTE
Device Name: Digital Breast Tomosynthesis
Device Class: 3
Physical State: Hardware and software for acquiring and reconstructing digital projection images. May incorporate similar equipment as full-field digital mammography systems.
Definition: To generate digital 3D mammographic images that can be used for the screening and diagnosis of breast cancer.
Submission Type ID: 2
Review Panel: RA
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: Projection images are acquired over the stationary breast and reconstructed to produce cross-sectional ¿slices¿ through the breast.
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: Breast
Regulation Number: N/A
Third Party Flag: N
Medical Specialty: N/A
Device IdentifiersDevice Id: 15420045510753
Device Type: Primary
DeviceId Issuing Agency: GS1
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A