# P080003: Selenia Dimensions Full Field Digital Mammography System

- Pathway: PMA
- Applicant: Hologic, Inc.
- Decided: Feb 11, 2011 after 1,116 days
- Product code: OTE (Digital Breast Tomosynthesis)
- Device class: 3
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

## Recalls of this device
- Apr 8, 2026 · Class II · Z-2168-2026: Complaints have been received of systems developing loose, missing, or broken internal bolts over time.
- Aug 19, 2024 · Class II · Z-3248-2024: Identified an issue with Selenia Dimensions 1.12.0 and 3Dimensions 2.3.0 system software when used in combination with C-View software in which the quality of the final C-View synthesized 2D image is 
- Jan 16, 2023 · Class II · Z-1144-2023: C-Arm unexpected movement may cause blunt trauma should the tube arm impinge upon an individual
- Jan 21, 2020 · Class II · Z-1343-2020: The recalling firm has received reports from the field of the C-arm on the Selenia Dimensions system seizing or dropping during field repairs and cleaning of the systems.

Source page: https://510kreport.com/device/P080003
Methodology: https://510kreport.com/methodology