# K121739: Ivue with Normative Database

- Pathway: 510(k) (Traditional)
- Applicant: Optovue, Inc.
- Decided: Jan 18, 2013 after 219 days
- Product code: HLI (Ophthalmoscope, Ac-Powered)
- Device class: 2
- Regulation: 21 CFR 886.1570
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K012727 (2002). 9 ancestors in all.
14 later devices descend from it; 6 cite it directly.
0 of 24 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.
- K101505: Rtvue Model Rtvue 100, Optovue, Inc. (2010) Summary page 2.

## Most influential descendants
- K161509: 3D OCT-1 Maestro (2016), 8 descendants of its own
- K170164: 3D OCT-1 Maestro (2017), 5 descendants of its own
- K231222: 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2) (2023), 3 descendants of its own
- K171370: IMAGEnet 6 Ophthalmic Data System (2017), 3 descendants of its own
- K233561: 3D Optical Coherence Tomography (3D OCT-1(type: Maestro2)) (2024), 2 descendants of its own

## Recalls of this device
- Jul 27, 2017 · Class II · Z-0008-2018: FDA determined that a 510(k) is needed for the Vault Mapping software (also known as Lens Fitting).
- Mar 16, 2016 · Class II · Z-1498-2016: A software anomaly was detected that affects Optovue iVue and iVue 500 with Normative Database that may display images of the same eye rather than right and left if user scrolls on the map.
- May 14, 2013 · Class III · Z-1441-2013: Colors from the NDB comparison for Ganglion Cell Complex thickness in the singular OU report in iVue version 3.0 (US) and 3.1(international) are different from those in the individual iWellness ID and

## Indications for use
The iVue is a non-contact, high resolution tomographic imaging device. It is intended for in vivo imaging, axial cross-sectional, and three-dimensional imaging and measurement of anterior and posterior ocular structures, including retina, retinal nerve fiber layer, ganglion cell complex (0CC), optic disc, cornea, and anterior chamber of the eye. The iVue with Normative Database is a quantitative tool for the comparison of retina, retinal nerve fiber layer, ganglion cell complex, and optic disc measurements to a database of known normal subjects. The iVue with Normative Database is indicated for use as a device to aid in the diagnosis, documentation, and management of ocular health and diseases in the adult population.

Source page: https://510kreport.com/device/K121739
Methodology: https://510kreport.com/methodology