# K062552: RTVUE

- Pathway: 510(k) (Traditional)
- Applicant: Optovue, Inc.
- Decided: Oct 6, 2006 after 37 days
- Product code: OBO (Tomography, Optical Coherence)
- 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: 1 generation back to K012727 (2002). 1 ancestor in all.
65 later devices descend from it; 3 cite it directly.
0 of 67 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012727: Humphrey OCT3, Carl Zeiss Ophthalmic Systems, Inc. (2002)

## Most influential descendants
- K071250: CA, Model: Cam (2007), 64 descendants of its own
- K101505: Rtvue Model Rtvue 100 (2010), 58 descendants of its own
- K111157: CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER, MACULAR, OPTIC NERVE HEAD, and GANGLION CELL NORMATIVE DATABASES (2012), 24 descendants of its own
- K120238: Rtvue XR Oct (2012), 17 descendants of its own
- K153080: RTVue XR OCT Avanti with AngioVue Software (2016), 16 descendants of its own

## Indications for use
The RTVue 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/K062552
Methodology: https://510kreport.com/methodology