# P160031: Aspire Cristalle Digital Breast Tomosynthesis Option

- Pathway: PMA
- Applicant: Fujifilm Medical Systems U.S.A, Inc.
- Decided: Jan 10, 2017 after 162 days
- Product code: OTE (Digital Breast Tomosynthesis)
- Device class: 3
- Recalls of this device: 1 (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
- Jun 11, 2025 · Class II · Z-2219-2025: Devices had an unapproved slabbing software function enabled for use.

Source page: https://510kreport.com/device/P160031
Methodology: https://510kreport.com/methodology