# K120982: Digital Eye-Fundus Camera

- Pathway: 510(k) (Traditional)
- Applicant: Medimaging Integrated Solutions, Inc. (Miis)
- Decided: Sep 28, 2012 after 179 days
- Product code: HKI (Camera, Ophthalmic, Ac-Powered)
- Device class: 2
- Regulation: 21 CFR 886.1120
- 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 K003376 (2001). 4 ancestors in all.
6 later devices descend from it; 3 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110986: Optomed Smartscope M5 EY3 and M5 ES1, Optomed OY (2011)

## Most influential descendants
- K180306: Nexy (2018), 2 descendants of its own
- K170470: Digital Eye Anterior Camera (2017), 1 descendant of its own
- K250683: Resolve Fundus Camera (2025), 0 descendants of its own
- K202221: VX650 (2021), 0 descendants of its own
- K193188: MiiS Horus Eye Anterior Camera (2020), 0 descendants of its own

## Indications for use
MiiS Horns Scope DEC 100 is a digital hand-held eye-fimndus camera used to record digital photographs and video of the frndus of the human eye and surrounding area.

Source page: https://510kreport.com/device/K120982
Methodology: https://510kreport.com/methodology