# K213620: ATUSA™ Automated 3D Breast Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Isono Health, Inc.
- Decided: Apr 22, 2022 after 157 days
- Product code: IYO (System, Imaging, Pulsed Echo, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K922470 (1992). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080555: Sofia Automated Tomographic Ultrasound (Atus), Ivu Imaging Corporation (2008) Summary page 4.

## Indications for use
The 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. Operator: Trained Healthcare Professional Patient Population: Ages 18 and above Environment of use: Facilities where healthcare is provided - e.g. hospitals, clinics, physician offices, mobile care units.

Source page: https://510kreport.com/device/K213620
Methodology: https://510kreport.com/methodology