# K091404: Ivue, Model 100

- Pathway: 510(k) (Traditional)
- Applicant: Optovue, Inc.
- Decided: Apr 22, 2010 after 345 days
- Product code: OBO (Tomography, Optical Coherence)
- Device class: 2
- Regulation: 21 CFR 886.1570
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K012727 (2002). 7 ancestors in all.
16 later devices descend from it; 2 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)
- K062552: RTVUE, Optovue, Inc. (2006) Summary page 1.
- K071250: CA, Model: Cam, Optovue, Inc. (2007) Summary page 1.

## Most influential descendants
- K121739: Ivue with Normative Database (2013), 14 descendants of its own
- 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

## Recalls of this device
- Sep 7, 2012 · Class II · Z-0024-2013: Devices labeled for an intended use not included in the existing 510(k) or PMA. Specifically, "The Retina" poster provided with the systems, and the book "RETINAL OCT Analysis and Interpretation Metho
- Jul 20, 2010 · Not classified · Z-1004-2011: Use of the CAM attachment may result in a positioning anomaly and mistreatment in the eyes of the patient.

## 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

Source page: https://510kreport.com/device/K091404
Methodology: https://510kreport.com/methodology