# K142926: iBreastExam

- Pathway: 510(k) (Abbreviated)
- Applicant: Ue Lifesciences, Inc.
- Decided: Apr 23, 2015 after 197 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: 1 generation back to DEN020001 (2003). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN020001: Breastview Visual Mapping System, Assurance Medical (2003). Our reading of the summary gave K010514, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN020001, Breastview Visual Mapping System (Assurance Medical), granted Jan 31, 2003; older De Novo requests were first filed under a 510(k) number, so this links to the grant.

## Most influential descendants
- K190575: iBreastExam (2019), 0 descendants of its own

## Indications for use
iBreastExam™ 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™ 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/K142926
Methodology: https://510kreport.com/methodology