# K070344: Liv Breast Self Examination Aid

- Pathway: 510(k) (Traditional)
- Applicant: Liv International USA, Inc.
- Decided: Mar 8, 2007 after 30 days
- Product code: IZH (System, X-Ray, Mammographic)
- Device class: 2
- Regulation: 21 CFR 892.1710
- 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 K955249 (1995). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023390: MY Breast Friend, Breast Self-Exam Pad, Mbf Sales, LLC (2002) Summary page 1.

## Indications for use
The Liv TM Breast Self Examination Aid is indicated as an aid for performing breast-self examinations.

Source page: https://510kreport.com/device/K070344
Methodology: https://510kreport.com/methodology