PMA P080003S009

Device: Envision Mammography Platform
Applicant: Hologic, Inc.
PMA number: P080003
Supplement: S009
Product code: OTE
Decision date: 2024-07-05
Classification: Radiology
Generic name: Digital breast tomosynthesis
Approval order statement: Approval for introduction of Envision Mammography Platform that include updated gantry with adjustable tilted C-Arm, detector electronics, user interfaces, anti-scatter grid, dynamic collimator, and introduction of X-ray source with moving focal spot.

Current openFDA PMA Record#

Device: Envision Mammography Platform
Applicant: Hologic, Inc.
PMA number: P080003
Supplement: S009
Product code: OTE
Generic name: Digital breast tomosynthesis
Decision date: 2024-07-05
Decision code: APPR
Date received: 2023-08-31
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for introduction of Envision Mammography Platform that include updated gantry with adjustable tilted C-Arm, detector electronics, user interfaces, anti-scatter grid, dynamic collimator, and introduction of X-ray source with moving focal spot.