# K190575: iBreastExam

- Pathway: 510(k) (Abbreviated)
- Applicant: Ue Lifesciences, Inc.
- Decided: Jul 16, 2019 after 132 days
- Product code: NKA (System, Documentation, Breast Lesion)
- Device class: 2
- Regulation: 21 CFR 884.2990
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to DEN020001 (2003). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142926: iBreastExam, Ue Lifesciences, Inc. (2015) Summary page 4.

## Indications for use
iBreastExam Gen II device is intended to produce a surface pressure map of the breast as an aid in documenting palpable breast lesions identified during a clinical breast exam. iBreastExam Gen II device is intended for use by a qualified healthcare professional trained in its use and is not for home use.

Source page: https://510kreport.com/device/K190575
Methodology: https://510kreport.com/methodology