# K063343: Bioptigen Spectral Domain Ophthalmic Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: Bioptigen, Inc.
- Decided: Dec 13, 2006 after 37 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: 3 generations back to K012727 (2002). 3 ancestors in all.
70 later devices descend from it; 2 cite it directly.
0 of 74 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033123: Stratusoct with RNFL & Macula Normative Database, Carl Zeiss Meditec, Inc. (2004) Summary page 1.
- K012727: Humphrey OCT3, Carl Zeiss Ophthalmic Systems, Inc. (2002) Summary page 1.

## 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 Bioptigen Spectral Domain Ophthalmic Imaging System is intended to acquire, process, display, and save depth-resolved images of ocular tissue microstructure using Spectral Domain Optical Coherence Tomography. It is primarily intended for the imaging of retinal tissue, but the cornea, sciera, and conjunctiva can also be imaged by changing the focal position. Indications for use include the evaluation of ophthalmic tissue in routine clinical examinations and as an aid in the diagnosis of conditions that affect the optical scattering properties of ocular tissue.

Source page: https://510kreport.com/device/K063343
Methodology: https://510kreport.com/methodology