# K120238: Rtvue XR Oct

- Pathway: 510(k) (Special)
- Applicant: Optovue, Inc.
- Decided: Apr 3, 2012 after 68 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.
17 later devices descend from it; 1 cites it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101505: Rtvue Model Rtvue 100, Optovue, Inc. (2010) Summary page 1.

## Most influential descendants
- K153080: RTVue XR OCT Avanti with AngioVue Software (2016), 16 descendants of its own
- K181594: Spectralis HRA+OCT and variants with OCT Angiography Module (2018), 8 descendants of its own
- K182569: Spectralis HRA+OCT and variants with High Magnification Module (2018), 7 descendants of its own
- K192391: Spectralis HRA+OCT and Variants (2019), 6 descendants of its own
- K201252: Spectralis HRA+OCT and variants (2020), 5 descendants of its own

## Indications for use
The RTVue XR with Normative Database is an optical coherence tomography system indicated for the in vivo imaging and measurement of the retina, retinal nerve fiber layer, and optic disc as a tool and aid in the diagnosis and management of retinal diseases by a clinician. The RTVue XR with Normative Database is also a quantitative tool for the comparison of retina, retinal nerve fiber layer, and optic disk measurements in the human eye to a database of known normal subjects. It is intended for use as a diagnostic device to aid in the detection and management of ocular diseases.

Source page: https://510kreport.com/device/K120238
Methodology: https://510kreport.com/methodology