# K092374: Ois Eyescan Portable Modular Imaging System, Model Ois Eyescan

- Pathway: 510(k) (Traditional)
- Applicant: Ophthalmic Imaging Systems
- Decided: Nov 17, 2009 after 104 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: 5 generations back to K941234 (1995). 13 ancestors in all.
22 later devices descend from it; 1 cites it directly.
0 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041367: Topcon Model TRC-NW200 Non-Mydriatic Retinal Camera, Topcon Corp. (2004) Summary page 3.
- K913929: DFC-1024 & DFC-512 Digital Imaging System, Ophthalmic Imaging Systems (1991) Summary page 3.
- K062295: Iri Integrated Retinal Imager, Medivision Medical Imaging, Ltd. (2006) Summary page 3.
- K982057: BC 900 Slit Lamp, Haag-Streit AG (1998) Summary page 3.
- K973064: Keeler Tearscope-Plus, Keeler Instruments, Inc. (1998) Summary page 4.

## Most influential descendants
- K101935: Centervue Digital Retinography System (2010), 21 descendants of its own
- K142047: EIDON (2014), 8 descendants of its own
- K122572: Icam Fundus Camera (2013), 8 descendants of its own
- K182199: NFC-700 non-mydriatic auto fundus camera (2019), 3 descendants of its own
- K180526: Eidon FA (2018), 2 descendants of its own

## Indications for use
The OIS EyeScan Portable Modular Imaging System is a portable monocular camera intended for imaging of both the posterior segment (including structures of the retina, vitreous and choroid) and anterior segment (including structures of the orbit, lids, cornea, iris and lens) of the eye. The device is suitable for documentation of findings in a clinical setting.

Source page: https://510kreport.com/device/K092374
Methodology: https://510kreport.com/methodology