# K103266: Istand

- Pathway: 510(k) (Traditional)
- Applicant: Optovue, Inc.
- Decided: Jun 3, 2011 after 211 days
- Product code: HLI (Ophthalmoscope, Ac-Powered)
- 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: 6 generations back to K012727 (2002). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091404: Ivue, Model 100, Optovue, Inc. (2010) Summary page 1.

## Indications for use
The iVue is an optical coherence tomography system indicated for the in vivo imaging and measurement of the retina, retinal nerve fiber layer, optic disk, cornea, and anterior chamber of the eye as an aid in the diagnosis and management of ocular diseases. The iStand is an optional accessory to the iVue which allows qualitative in-vivo imaging in cooperative, supine patients.

Source page: https://510kreport.com/device/K103266
Methodology: https://510kreport.com/methodology