# K222166: SOLIX

- Pathway: 510(k) (Traditional)
- Applicant: Optovue, Inc.
- Decided: Nov 9, 2022 after 111 days
- Product code: OBO (Tomography, Optical Coherence)
- Device class: 2
- Regulation: 21 CFR 886.1570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K012727 (2002). 36 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180660: Avanti, Optovue, Inc. (2018) Summary page 4.
- K122572: Icam Fundus Camera, Optovue, Inc. (2013) Summary page 4.

## Most influential descendants
- K251848: Pentacam® Cornea OCT (2026), 0 descendants of its own

## Indications for use
SOLIX™ is an optical coherence tomography system intended for the in vivo imaging, cross-sectional, and the three-dimensional imaging and measurement of anterior and posterior ocular structures, including retina, retinal nerve fiber layer, ganglion cell complex (GCC), optic disc, cornea, corneal epithelium, corneal stroma, pachymetry, and anterior chamber of the eye. With the integrated reference database, SOLIX™ is also a quantitative tool for the comparison of the retina, retinal nerve fiber layer, and optic disc measurements in the human eye to a database of known normal subjects. It is indicated for use as a diagnostic device to aid in the detection and management of ocular diseases. The SOLIX™ with the AngioVue software feature is indicated as an aid in the visualization of vascular structures of the retina and choroid in normal subjects, and in subjects with glaucoma and retinal diseases. The AngioAnalytics software feature of AngioVue is indicated for the measurement of vascular density, the foveal avascular zone, the thickness of retinal layers, and nerve fiber layer, and measurement of optic disc parameters in normal subjects, and in subjects with glaucoma and retinal diseases. The non-mydriatic color fundus camera of SOLIX™ is an integrated non-contact, high resolution digital imaging component which is suitable for photographing, displaying and storing images of the retina and external areas of the eye to be evaluated under non-mydriatic conditions. The SOLIX™ fundus camera component is indicated for in-vivo viewing of the posterior and external area of the eye and the images are intended for use as an aid to clinicians in the evaluation, diagnosis and documentation of ocular health.

Source page: https://510kreport.com/device/K222166
Methodology: https://510kreport.com/methodology