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PMA P080003S007

Device
Selenia Dimensions / 3Dimensions
Applicant
Hologic, Inc.
PMA number
P080003
Supplement
S007
Product code
OTE
Decision date
2018-06-22
Classification
Digital Breast Tomosynthesis
Generic name
Digital breast tomosynthesis
Approval order statement
Approval for a change to the Selenia Dimensions/3Dimensions detector subsystem for approval of a new Application Specific Integrated Circuit (ASIC), and also the necessary changes to some of the detector PCB hardware, detector embedded software and detector firmware in order to support dual sourcing.

Current openFDA PMA Record#

Device
Selenia Dimensions / 3Dimensions
Applicant
Hologic, Inc.
PMA number
P080003
Supplement
S007
Product code
OTE
Generic name
Digital breast tomosynthesis
Decision date
2018-06-22
Decision code
APPR
Date received
2018-05-02
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for a change to the Selenia Dimensions/3Dimensions detector subsystem for approval of a new Application Specific Integrated Circuit (ASIC), and also the necessary changes to some of the detector PCB hardware, detector embedded software and detector firmware in order to support dual sourcing.