# K111505: Rtvue Cam with Corneal Power Upgrade

- Pathway: 510(k) (Traditional)
- Applicant: Optovue, Inc.
- Decided: Sep 8, 2011 after 100 days
- Product code: OBO (Tomography, Optical Coherence)
- Device class: 2
- Regulation: 21 CFR 886.1570
- Recalls of this device: 1 (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). 11 ancestors in all.
8 later devices descend from it; 2 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071250: CA, Model: Cam, Optovue, Inc. (2007) Summary page 2.
- K030719: Pentacam Scheimpflug Camera, Oculus Optikgerate GmbH (2003) Summary page 2.

## Most influential descendants
- K180660: Avanti (2018), 5 descendants of its own
- K222166: SOLIX (2022), 1 descendant of its own
- K213265: Tomey Cornea/Anterior Segment OCT CASIA2 (2022), 1 descendant of its own
- K121622: Nidek RS-3000 (2013), 1 descendant of its own
- K251848: Pentacam® Cornea OCT (2026), 0 descendants of its own

## Recalls of this device
- Feb 21, 2012 · Not classified · Z-1340-2012: A few doctors in the US were inadvertently sent the Cornea Power software version kit for international users instead of the domestic version.

## Indications for use
The CA, an auxiliary lens adapter, when used in conjunction with RTVue, is indicated for in vivo imaging and measurement of the cornea and other ocular structures of the anterior segment of the eye, including pachymetry and comneal power.

Source page: https://510kreport.com/device/K111505
Methodology: https://510kreport.com/methodology