# K161871: EVA (Enhanced Visual Assessment) System

- Pathway: 510(k) (Traditional)
- Applicant: Mobileodt, Ltd.
- Decided: Dec 19, 2016 after 165 days
- Product code: HEX (Colposcope (And Colpomicroscope))
- Device class: 2
- Regulation: 21 CFR 884.1630
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K940094 (1995). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122973: AL-106, AL-106SA and AL-106B Medgyn Digital Video Colposcope, Medgyn Products, Inc. (2013) Summary page 4.

## Most influential descendants
- K202915: IRIS Thermocoagulator and Digital Colposcope (2021), 0 descendants of its own

## Indications for use
The EVA (Enhanced Visual Assessment) System is intended to provide magnified viewing of the vagina, cervix and external genitalia in order to aid in diagnosing abnormalities and selecting areas for biopsy. The device is intended for use in hospitals, doctor’s offices, and remote and rural clinics.

Source page: https://510kreport.com/device/K161871
Methodology: https://510kreport.com/methodology