# K100861: R T Vue with Software 5.0 Model: R I Vue 100

- Pathway: 510(k) (Special)
- Applicant: Optovue, Inc.
- Decided: Jun 17, 2010 after 83 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: 5 generations back to K012727 (2002). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 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.

## Indications for use
The RTVue with Software 5.0 is an optical coherence tomography system indicated for the in vivo imaging and measurement of the retina, retinal nerve fiber layer, and optic disk as an aid in the diagnosis and management of retinal diseases.

Source page: https://510kreport.com/device/K100861
Methodology: https://510kreport.com/methodology