# DEN020001: Breastview Visual Mapping System

- Pathway: De Novo (Post-NSE)
- Applicant: Assurance Medical
- Decided: Jan 31, 2003 after 248 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
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K142926: iBreastExam (2015), 1 descendant of its own
- K190575: iBreastExam (2019), 0 descendants of its own
- K181672: SureTouch Mobile Pressure Mapping System (2019), 0 descendants of its own

Source page: https://510kreport.com/device/DEN020001
Methodology: https://510kreport.com/methodology