# K180660: Avanti

- Pathway: 510(k) (Traditional)
- Applicant: Optovue, Inc.
- Decided: Jun 8, 2018 after 86 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: 8 generations back to K012727 (2002). 15 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153080: RTVue XR OCT Avanti with AngioVue Software, Optovue, Inc. (2016) Summary page 4.
- K111505: Rtvue Cam with Corneal Power Upgrade, Optovue, Inc. (2011) Summary page 4.

## Most influential descendants
- K222166: SOLIX (2022), 1 descendant of its own
- K213265: Tomey Cornea/Anterior Segment OCT CASIA2 (2022), 1 descendant of its own
- K251848: Pentacam® Cornea OCT (2026), 0 descendants of its own
- K250553: Tomey Cornea/Anterior Segment OCT (CASIA2) (2025), 0 descendants of its own
- K221320: Scanning Laser Ophthalmoscope Mirante [SLO/OCT Model] with Image Filing Software NAVIS-EX; Scanning Laser Ophthalmoscope Mirante [SLO Model] with Image Filing Software NAVIS-EX (2023), 0 descendants of its own

## Indications for use
The Avanti is an optical coherence tomography system intended for the in vivo imaging, cross-sectional, and 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 epithelia, corneal stroma, pachymetry, corneal power, and anterior chamber of the eye. With the integrated normative database, Avanti is also a quantitative tool for the comparison of retina, retinal nerve fiber layer, and optic disc measurements in the human eye to a database of a known normal subjects. It is indicated for use as a diagnostic device to aid in the detection and management of ocular diseases. The Avanti 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.

Source page: https://510kreport.com/device/K180660
Methodology: https://510kreport.com/methodology