# K102412: Vista Digital Opthalmoscope

- Pathway: 510(k) (Traditional)
- Applicant: Eyequick.Llc
- Decided: Jun 23, 2011 after 303 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: 2 generations back to K912891 (1991). 9 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050271: Kowa Genesis-D Hand-Held Retinal Camera, Kowa Co., Ltd. (2005) Summary page 1.
- K053425: Precision Optics Corporation Video Ophthalmoscope, Model 2500-Vos, Precision Optics Corp. (2006) Summary page 1.
- K950461: Welch Allyn Ophthalmoscope, Welch Allyn, Inc. (1995) Summary page 1.
- K974535: Discam Digital Imaging System, Marcher Enterprises, Ltd. (1998) Summary page 1.

## Most influential descendants
- K121405: Panoptic (2012), 1 descendant of its own
- K223381: iExaminer System with Panoptic Plus (2023), 0 descendants of its own

## Indications for use
The EyeQuick Digital Ophthalmoscope Camera is intended for use in capturing approximately eight degrees narrow angle field of view images of the eyelids, retina and the anterior segment of the eye.

Source page: https://510kreport.com/device/K102412
Methodology: https://510kreport.com/methodology