PMA P080003S005

Device: Selenia Dimensions 3D System.
Applicant: Hologic, Inc.
PMA number: P080003
Supplement: S005
Product code: OTE
Decision date: 2017-05-23
Classification: Digital Breast Tomosynthesis
Generic name: Digital breast tomosynthesis
Approval order statement: Approval for a change to the Physician Labeling of the Selenia Dimensions 3D System and the Selenia Dimensions 3D System with C-View Software Module, to claim superior screening accuracy of 3D plus 2D imaging, where the 2D image can be either a synthesized 2D or a Full Field Digital Mammography (FFDM) image, as compared to FFDM alone, for women with dense breasts.

Current openFDA PMA Record#

Device: Selenia Dimensions 3D System.
Applicant: Hologic, Inc.
PMA number: P080003
Supplement: S005
Product code: OTE
Generic name: Digital breast tomosynthesis
Decision date: 2017-05-23
Decision code: APPR
Date received: 2017-05-02
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for a change to the Physician Labeling of the Selenia Dimensions 3D System and the Selenia Dimensions 3D System with C-View Software Module, to claim superior screening accuracy of 3D plus 2D imaging, where the 2D image can be either a synthesized 2D or a Full Field Digital Mammography (FFDM) image, as compared to FFDM alone, for women with dense breasts.