# K080555: Sofia Automated Tomographic Ultrasound (Atus)

- Pathway: 510(k) (Traditional)
- Applicant: Ivu Imaging Corporation
- Decided: Jun 3, 2008 after 96 days
- Product code: ITX (Transducer, Ultrasonic, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 892.1570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K922470 (1992). 9 ancestors in all.
53 later devices descend from it; 3 cite it directly.
0 of 63 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032640: Full Field Breast Imaging (Ffbu) Diagnostic Ultrasound System, U-Systems, Inc. (2003) Summary page 2.
- K052355: Automated Breast Ultrasound System, Model Abus, U-Systems, Inc. (2005) Summary page 2.

## Most influential descendants
- K123209: Softvue (2013), 50 descendants of its own
- K142517: SoftVue (2014), 49 descendants of its own
- K150949: FibroScan (2015), 42 descendants of its own
- K160524: FibroScan 530 Compact (2016), 41 descendants of its own
- K170445: Logiq S8 (2017), 19 descendants of its own

## Indications for use
The Sofia TM (ATUS) device is indicated for use as a B-mode ultrasonic imaging system for imaging of a patient's breast when used with an automatic scanning linear array transducer. The device is not intended to be used as a replacement for screening mammography.

Source page: https://510kreport.com/device/K080555
Methodology: https://510kreport.com/methodology