# K101505: Rtvue Model Rtvue 100

- Pathway: 510(k) (Traditional)
- Applicant: Optovue, Inc.
- Decided: Sep 15, 2010 after 106 days
- Product code: HLI (Ophthalmoscope, Ac-Powered)
- 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). 7 ancestors in all.
58 later devices descend from it; 4 cite it directly.
0 of 66 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 1.
- K033123: Stratusoct with RNFL & Macula Normative Database, Carl Zeiss Meditec, Inc. (2004) Summary page 1.

## Most influential descendants
- 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
- K121739: Ivue with Normative Database (2013), 14 descendants of its own
- K112184: Cirrus Photo (2012), 13 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

## Indications for use
The RTVue 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 disk as an aid in the diagnosis and management of retinal disease. The RTVue 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/K101505
Methodology: https://510kreport.com/methodology