# K070477: Orison Embrace System

- Pathway: 510(k) (Traditional)
- Applicant: Orison Corporation
- Decided: Mar 9, 2007 after 17 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: 4 generations back to K922470 (1992). 9 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052355: Automated Breast Ultrasound System, Model Abus, U-Systems, Inc. (2005) Summary page 1.

## Most influential descendants
- K082543: Sonocine Adjunctive Breast Ultrasound System (Abu), Model 100 (2008), 2 descendants of its own
- K161354: MELODY, Remote Control System for Ultrasound Probe (2017), 1 descendant of its own
- K260190: Arthur (2026), 0 descendants of its own

## Indications for use
The Orison Embrace is indicated for use as an adjunct to mammography for B-mode ultrasonic imaging of the patients breast when used with an automatic scanning linear array transducer.

Source page: https://510kreport.com/device/K070477
Methodology: https://510kreport.com/methodology