# K163021: Haag-Streit Fundus Module 300

- Pathway: 510(k) (Traditional)
- Applicant: Optomed OY
- Decided: Apr 11, 2017 after 162 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: 4 generations back to K003376 (2001). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132186: Optomed Smartscope M5 / Optomed Smartscope EY4 / Optomed Smartscope ES2, Optomed OY (2013) Summary page 4.

## Indications for use
FUNDUS MODULE 300 is an ophthalmic camera that is used as an accessory with dedicated slit lamps to capture digital images and video of the fundus of the human eye.

Source page: https://510kreport.com/device/K163021
Methodology: https://510kreport.com/methodology