# P110006: Somo.V Abus (Automated Breast Ultrasound System)

- Pathway: PMA
- Applicant: GE Healthcare
- Decided: Sep 18, 2012 after 585 days
- Product code: PAA (Automated Breast Ultrasound)
- 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
- May 16, 2013 · Class II · Z-1587-2013: Devices labeled for an intended use not included in the existing 510(k) or PMA, in that, the user manual contains the Indication for Use of the soma v Platinum ABUS [a 510(k) product].

Source page: https://510kreport.com/device/P110006
Methodology: https://510kreport.com/methodology